FDA Recalls
GE Healthcare Integrated IT Solutions - GE Centricity PACS RA1000 Workstation - Class 2 Recall
Thu, 01 May 2008
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
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Stryker Instruments Div. of Stryker Corporation - Stryker ACM bowl without cartridge - Class 2 Recall
Thu, 01 May 2008
Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
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Siemens Medical Solutions USA, Inc - Primeview 3i 2.1 - Class 2 Recall
Wed, 30 Apr 2008
Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Coherence Therapist system 2.1 - Class 2 Recall
Wed, 30 Apr 2008
Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Impression Therapist - Class 2 Recall
Wed, 30 Apr 2008
Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Coherence Therapist 2.1 - Class 2 Recall
Wed, 30 Apr 2008
Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2. Siemens AG, Concord, CA.
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Siemens Medical Solutions USA, Inc - AG Therapist - Class 2 Recall
Wed, 30 Apr 2008
Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Syngo - Class 2 Recall
Wed, 30 Apr 2008
Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437. Siemens AG, Concord, CA.
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Siemens Medical Solutions USA, Inc - Coherence Therapist 2.0 - Class 2 Recall
Wed, 30 Apr 2008
Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Primeview 3i - Class 2 Recall
Wed, 30 Apr 2008
Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA.
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Siemens Medical Solutions USA, Inc - Coherence AG Therapist - Class 2 Recall
Wed, 30 Apr 2008
Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Coherence Impression Therapist - Class 2 Recall
Wed, 30 Apr 2008
Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
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Siemens Medical Solutions USA, Inc - Primeview 3i 2.0 - Class 2 Recall
Wed, 30 Apr 2008
Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0. Siemens AG, Concord, CA.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46 - Class 2 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Siemens Medical Solutions USA, Inc - Leonardo Workstation - Class 2 Recall
Tue, 29 Apr 2008
Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
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Seradyn, Inc. - Seradyn QMS Vancomycin - Class 2 Recall
Tue, 29 Apr 2008
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
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Abbott Laboratories - Hemoglobin Reagent Syringe Used on the CELL-DYN Sapphire Automated Hematology Analyzer - Class 2 Recall
Thu, 24 Apr 2008
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
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Respironics, Inc. - M Series Heated Humidifier Domestic - Class 2 Recall
Thu, 24 Apr 2008
M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Rotating Connector Packaged - Class 2 Recall
Thu, 24 Apr 2008
Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP Diaphragm Exhalation - Class 2 Recall
Thu, 24 Apr 2008
RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model number DS200H; d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS; e) REMStar Plus M w/Smartcard, US model number DS200S; and f) REMStar Plus w/C Flex Dom model number 1009586. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP-Cable DC 6 w/Ring PLV RBL POR - Class 2 Recall
Thu, 24 Apr 2008
RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP-REMStar Plus Keypad - Class 2 Recall
Thu, 24 Apr 2008
RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x ¿ 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Breathing Frequency Monitor Stardust 2 Domestic - Class 2 Recall
Thu, 24 Apr 2008
Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Oximeter Patient Cable Masimo 8 ft - Class 2 Recall
Thu, 24 Apr 2008
Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Oximetry Ear Clip Sensor - Class 2 Recall
Thu, 24 Apr 2008
Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Omni Lab Core Domestic - Class 2 Recall
Thu, 24 Apr 2008
Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP M Series Pollen Filter Kit 1 pack - Class 2 Recall
Thu, 24 Apr 2008
RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) REMStar M US model number DS100 and b) REMStar M w/Humid US model number DS100H. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Filters - Class 2 Recall
Thu, 24 Apr 2008
Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193; d) RP-M Series Ultrafine Filters 6 pack model number 1029331; e) RP Vision OM Reg Filter (ASCO) model number 1007547; and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 ¿ inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - power cords - Class 2 Recall
Thu, 24 Apr 2008
Power Cord Accessory under the following brand names a) Power Cord W/C7 End Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model number 1005894. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - power supply - Class 2 Recall
Thu, 24 Apr 2008
Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Lead Wire Pin/Socket 24 in 1 pr - Class 2 Recall
Thu, 24 Apr 2008
Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - REMStar Heated Humidifier Pkg - Class 2 Recall
Thu, 24 Apr 2008
REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Inv Circuit Assembly Box 10 CE - Class 2 Recall
Thu, 24 Apr 2008
Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/Smartcard US model number DS400S; d) REMStar Pro/Plus Silencer Cap model number 1005962; e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964; f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389; g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945; and h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Mouthpiece, Angled 22mm CE model number FC06566 - Class 2 Recall
Thu, 24 Apr 2008
Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - PLV-102, 100V 50/60 HZ Japanese - Class 2 Recall
Thu, 24 Apr 2008
PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel Cush and Flap model number 1031404 and b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP-Assy, Cover, DC-5 pack - Class 2 Recall
Thu, 24 Apr 2008
RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP Duet LX/Pro Out Port w/Seal - Class 2 Recall
Thu, 24 Apr 2008
RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP-Leaf, Check valve-5 pk - Class 2 Recall
Thu, 24 Apr 2008
RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - APNEA monitors - Class 2 Recall
Thu, 24 Apr 2008
APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Stardust Flexible Y Sensor Probe - Class 2 Recall
Thu, 24 Apr 2008
Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - ECG Lead Set 60 in SOC to Snap - Class 2 Recall
Thu, 24 Apr 2008
ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP C-Flex Mini Din Plug - Class 2 Recall
Thu, 24 Apr 2008
RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - RP-REM Auto w/C-FLEX/REM Pro Tubing Kit and RP-REM Power Cord N. AMER - Class 2 Recall
Thu, 24 Apr 2008
RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N. AMER model number 362524. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S; d) REMStar Auto M. w/Smartcard, CNDA model number CA501S; e) REMStar Auto M w/Smartcard Intl model number IN501S; f) REMStar Auto M w/Smartcard US model number DS500S; g) REMStar Auto w/C-FLEX CANADA model number CA1017454; and h) REMStar Auto w/C-FLEX Domestic Core Pkg model number 1017476. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/CAN model number 1010771; b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771; c) Synchrony S w/o modem US/CAN model number 1002816; d) Tranquility Ultrafine Qty 1 model number 1039671; and e) Tubing Coupler model number 300065. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Respironics, Inc. - Non-continuous ventilators - Class 2 Recall
Thu, 24 Apr 2008
Non-continuous ventilators accessories under the following brand names: a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS and b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA511HS. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Siemens Medical Solutions USA, Inc. - ACUSON Sequoia Diagnostic Ultrasound System - Class 2 Recall
Thu, 24 Apr 2008
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
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Respironics, Inc. - BIPAP AUTO, CORE PACKAGE - Class 2 Recall
Thu, 24 Apr 2008
BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-30-60.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-160.
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Stryker Instruments Div. of Stryker Corporation - TPS bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 3.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-30.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 4.7mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-47.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 7.8mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-775.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 5.0mm Round Fluted Bur, Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-50.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-60.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 9.1 x 11.4 mm Acorn Bur, Extra Long, Stryker Instruments, Kalamazoo, MI; REF 5160-30-90.
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Stryker Instruments Div. of Stryker Corporation - TPS Router - Class 2 Recall
Tue, 22 Apr 2008
Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-71-223.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-60.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-123.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Instruments 6.5mm Round Fluted Bur Extra Long for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-65.
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Stryker Instruments Div. of Stryker Corporation - TPS bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 5.0mm Round Fluted Bur,Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-50.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6.0 mm Barrel Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-17-60.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6.0mm x 8.0mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-60.
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Stryker Instruments Div. of Stryker Corporation - TPS RASP - Class 2 Recall
Tue, 22 Apr 2008
Stryker 32.mm x 18.3mm Heliocoidal Rasp Super Long, for use with "RX" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-80-30.
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Stryker Howmedica Osteonics Corp. - GMRS Proximal Femoral Surgical Protocol - Class 2 Recall
Tue, 22 Apr 2008
Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Stryker Orthopaedics, Mahwah, NJ 07430
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-90.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-105.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-30-75.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 8.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-80.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-150.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-775.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 7.5mm x 9.5mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-75.
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Stryker Instruments Div. of Stryker Corporation - TPS Drill - Class 2 Recall
Tue, 22 Apr 2008
Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long "AM" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5230-107-530S1.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-47.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-775.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 6.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-60.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 9.1mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-991.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 9.0mm x 11.4mm Acorn Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-30-90.
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Bio-Rad Laboratories Inc - BioPlex 2200 - Class 2 Recall
Tue, 22 Apr 2008
BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 7.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-70.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 9.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-90.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-140.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-170.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-70.
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Stryker Instruments Div. of Stryker Corporation - TPS bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-60.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-75.
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Stryker Instruments Div. of Stryker Corporation - TPS drill bit - Class 2 Recall
Tue, 22 Apr 2008
Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-107-30.
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Stryker Instruments Div. of Stryker Corporation - TPS bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-105.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 9.1mm x 7.9mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-991.
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Stryker Instruments Div. of Stryker Corporation - TPS Router - Class 2 Recall
Tue, 22 Apr 2008
Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31.
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Stryker Instruments Div. of Stryker Corporation - TPS router - Class 2 Recall
Tue, 22 Apr 2008
Stryker 3.0mm x 34.9mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-230.
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Stryker Instruments Div. of Stryker Corporation - TPS - Class 2 Recall
Tue, 22 Apr 2008
Stryker Instruments Minor modification product, 550-19-20 with 304.8mm length, sterile, product of Ireland, Stryker Instruments, Kalamazoo, MI; REF 5500019020S3.
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Stryker Instruments Div. of Stryker Corporation - TPS Drum - Class 2 Recall
Tue, 22 Apr 2008
Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-20-123.
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Stryker Instruments Div. of Stryker Corporation - TPS Bur - Class 2 Recall
Tue, 22 Apr 2008
Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-100.
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Stryker Instruments Div. of Stryker Corporation - TPS Router - Class 2 Recall
Tue, 22 Apr 2008
Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-70-31.
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Becton Dickinson & Company - BD 5 ml Syringe Luer Lok Tip - Class 2 Recall
Wed, 16 Apr 2008
BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder Number: 309703, BD, Franklin Lakes, NJ 07417.
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Becton Dickinson & Company - BD 10 ml Syringe Luer Lok Tip - Class 2 Recall
Wed, 16 Apr 2008
BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417.
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Cook, Inc. - Cook TPN Single Lumen Catheter Set - Class 2 Recall
Wed, 16 Apr 2008
Cook TPN Single Lumen Catheter set; Catheter introducer, includes 6.5 FRENCH, 90 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 18 Gage., 7 cm long, sterile; Catalog Number: C-TPNS-6.5-90-REDO. Cook Inc., Bloomington, IN 47404.
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Cook, Inc. - Peel-Away Introducer set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491. William Cook Europe A/S, Cook Inc., Bloomington, IN 47404.
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Cook, Inc. - Peel-Away Introducer Set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Catheter Introducer - Class 2 Recall
Wed, 16 Apr 2008
Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Minipuncture Peel-Away Introducer set - Class 2 Recall
Wed, 16 Apr 2008
Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-25-E-MNP. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Peel-Away Introducer set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.
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Cook, Inc. - Cook TPN Double Lumen Catheter Set - Class 2 Recall
Wed, 16 Apr 2008
Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 FRENCH, 65 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 19UT Gage., 7 cm long, sterile; Catalog Number: C-TPNS-6.0D-65. Cook Inc., Bloomington, IN 47404.
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Cook, Inc. - Peel-Away Introducer Set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile, Catalog Number: C-PLI-7.0-35-X-1. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Peel-Away Introducer Set Without Wire Guide - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Peel-Away Introducer set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLI-7.0-38. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Peel-Away Introducer Set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Peel-Away Introducer Set Without Wire Guide - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-38. Cook Inc., Bloomington, IN 47404
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Cook, Inc. - Peel-Away Introducer set - Class 2 Recall
Wed, 16 Apr 2008
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-38. Cook Inc., Bloomington, IN 47404
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Nonin Medical, Inc - Oximeter - Class 2 Recall
Fri, 11 Apr 2008
Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA
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Ormco Corporation - Grengloo (Unidose Tips) - Class 2 Recall
Thu, 10 Apr 2008
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740
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Myelotec, Inc. - Myelotec¿ Steerable Video Guided Catheter - Class 2 Recall
Thu, 10 Apr 2008
Myelotec¿ Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076.
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Myelotec, Inc. - Myelotec¿ Steerable Video Guided Catheter - Class 2 Recall
Thu, 10 Apr 2008
Myelotec¿ Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
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BD Biosciences - BD FACS Sample Prep Assistant II - Class 2 Recall
Thu, 10 Apr 2008
BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-003-10; 400 ml INF. Cntrl. Kit w/ 3/16" drain, 4.8 mm, 15Fr, PVC, 107 cm, soft, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-050-10; 400 ml Infection Control Comp. Kit, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-004-10; 400 ml INF. Cntrl. Kit w/ 1/4" drain, 6.4 mm, 19Fr, PVC, 107 cm, large, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF. CNTRL. Kit W/ 3/16" Drain Spec., 4.8mm, 15Fr., PVC, 107cm, soft, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-702-10; 400 ml INF. CNTRL. Kit W/ 1/8" Drain Spec., 3.2mm, 10Fr., PVC, 107cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-002-10, 400 ml-INF. Cntrl. Kit w/ 1/8" drain, 3.2 mm, 10Fr, PVC, 107 cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-704-10; 400 ml INF. CNTRL. Kit w/ 1/4" Drain Spec., 6.4mm., 19Fr., PVC, 107cm, large, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number: 47-2550-050-10; 400 ml evacuators and 450 ml collection bags, evaluator tubing and universal Y connectors, adapters for silicone drains, contains 10, non-sterile, latex-free, Zimmer, Dover, Ohio.
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Zimmer Inc. - Zimmer Hemovac Wound Drainage Device Infection Control Kits - Class 2 Recall
Wed, 09 Apr 2008
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
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Lumenis, Inc. - Laser Surgical Fiber - Class 2 Recall
Wed, 09 Apr 2008
Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.
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Boston Scientific Corporation - Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36 - Class 3 Recall
Wed, 30 Apr 2008
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760
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Straumann Usa, Llc - Straumann NC Closure Screw - Class 3 Recall
Wed, 30 Apr 2008
Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
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Beckman Coulter Inc - Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1 - Class 3 Recall
Wed, 30 Apr 2008
Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834
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Beckman Coulter Inc - Cytomics FC 500 Flow Cytometry System with CXP Software, Software Version 2.2 - Class 3 Recall
Wed, 30 Apr 2008
Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834
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