Apparatus, Autotransfusion
FDA product code CAC · Class II (moderate risk) · 21 CFR 868.5830 · Anesthesiology
195510(k) clearances
0PMA approvals
68recalls
Manufacturers
- Haemonetics Corporation 18
- Boehringer Laboratories 12
- Shiley, Inc. 11
- Deknatel, Inc. 11
- Atrium Medical Corporation 10
- Sorensen Research 7
- Electromedics, Inc. 7
- Cobe Cardiovascular, Inc. 7
- Solco Basle, Inc. 7
- Sorin Group Italia S.R.L. 6
- Davol, Inc. 5
- Fresenius Kabi AG 4
- Impra, Inc. 4
- Sherwood Medical Co. 4
- Inari Medical, Inc. 3
- Conmedcorp 3
- Teleflexmedical, Inc. 3
- Transfusion Technologies Corp. 3
- Baxter Healthcare Corp 3
- Cobe Laboratories, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | Sorin Group Italia S.R.L. | 08/16/2024SE |
| K240426 | Aventus Clot Management SystemCAC · Traditional | Inquis Medical | 05/14/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
| K231782 | FlowSaver Blood Return System (80-101)CAC · Special | Inari Medical, Inc. | 07/14/2023SE |
| K221483 | FlowSaver Blood Return SystemCAC · Traditional | Inari Medical, Inc. | 02/17/2023SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
| K193361 | ProCell Surgical Sponge-Blood Recovery UnitCAC · Traditional | Procell Surgical, Inc. | 06/01/2020SE |
| K192368 | CATSmartCAC · Special | Fresenius Kabi AG | 09/27/2019SE |
| K180831 | CATSmartCAC · Traditional | Fresenius Kabi AG | 12/10/2018SE |
| K181954 | autoLog IQ Autotransfusion SystemCAC · Special | Medtronic Perfusion Systems | 08/22/2018SE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC · Traditional | Haemonetics Corporation | 01/03/2017SE |
| K160735 | CATSmartCAC · Traditional | Fresenius Kabi AG | 09/16/2016SE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | Haemonetics Corporation | 05/24/2016SE |
| K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemCAC · Traditional | Teleflexmedical, Inc. | 10/23/2014SE |
| K140197 | Pleur-Evac Plus Continuous Reinfusion and Autotransfusion SystemCAC · Traditional | Teleflexmedical, Inc. | 10/21/2014SE |
| K131553 | XtraCAC · Traditional | Sorin Group Deutschland GmbH | 03/21/2014SE |
| K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemCAC · Special | Teleflexmedical, Inc. | 02/12/2013SE |
| K120953 | Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemCAC · Traditional | Tlelflex Medical, Inc. | 12/10/2012SE |
| K122262 | Orthopat Advance Perioperative Autotransfusion SystemCAC · Traditional | Haemonetics Corp. | 10/25/2012SE |
| K120586 | Cell Saver EliteCAC · Traditional | Haemonetics Corp. | 05/22/2012SE |
| K112245 | XtraCAC · Special | Sorin Group Italia S.R.L. | 09/06/2011SE |
| K110782 | XvacCAC · Traditional | Sorin Group Italia S.R.L. | 04/07/2011SE |
| K101907 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | Haemonetics Corp. | 12/03/2010SE |
| K103202 | Preassembled Surgical Wash SetCAC · Special | Sorin Group Italia S.R.L. | 11/23/2010SE |
| K101586 | Xtra Autotransfusion SystemCAC · Traditional | Sorin Group Italia S.R.L. | 10/05/2010SE |
| K093535 | Autolog Autotransfusion SystemCAC · Traditional | Medtronic, Inc. | 03/22/2010SE |
| K082923 | Prlong, Models PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C…CAC · Special | Life-Tech, Inc. | 10/24/2008SE |
| K060482 | Cytori Celution Cell Concentration DeviceCAC · Traditional | Cytori Therapeutics, Inc. | 09/28/2006SE |
| K053000 | Haemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat)CAC · Special | Haemonetics Corp. | 11/21/2005SE |
| K043127 | Haemonetics Cardiovascular Perioperative Autotransfusion SystemCAC · Traditional | Haemonetics Corp. | 01/04/2005SE |
| K043140 | Express and Oasis Chest DrainCAC · Special | Atrium Medical Corp. | 12/08/2004SE |
| K041525 | Hemovac Blood Reinfusion SystemCAC · Traditional | Zimmer, Inc. | 10/14/2004SE |
| K031554 | S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemCAC · Traditional | Genzyme Biosurgery | 07/25/2003SE |
| K022167 | Pall Doner Pre-Evacuated Post-Operative Autologous Blood Reinfusion SystemCAC · Traditional | Pall Corp. | 03/07/2003SE |
| K024097 | Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models AB400-10…CAC · Traditional | Summit Medical , Ltd. | 02/14/2003SE |
| K022489 | Summit Medical Ltd Celltrans Postoperative Autotransfusion System, Models ABT4510…CAC · Traditional | Summit Medical , Ltd. | 10/09/2002SE |
| K020647 | Dideco ElectaCAC · Abbreviated | Dideco S.P.A. | 09/05/2002SE |
| K022348 | Access Concentration System, Model ACC-100, Access Disposable Set, Model ADS-2000CAC · Special | Interpore Cross Intl. | 08/15/2002SE |
| K012406 | Access Sequestration SystemCAC · Traditional | Interpore Cross Intl. | 03/26/2002SE |
| K014187 | Autovac Orthopedic Autotransfusion SystemCAC · Traditional | Boehringer Laboratories | 02/06/2002SE |
| K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery SystemCAC · Special | Haemonetics Corp. | 01/08/2002SE |
| K012178 | Fresenius C.A.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; Psq-Dd Plasma…CAC · Special | Fresenius Hemotechnology, Inc. | 07/23/2001SE |
| K993581 | Haemonetics LN 193 Disposable Set, for Use with the Haemonetics Cellsever Haemolite 2…CAC · Special | Haemonetics Corp. | 11/18/1999SE |
| K992723 | Orthopedic Perioperative Autotransfusion (Orthopat) SystemCAC · Traditional | Transfusion Technologies Corp. | 10/18/1999SE |
| K991986 | Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling…CAC · Traditional | Cobe Cardiovascular, Inc. | 09/09/1999SE |
| K983022 | Smartcell Processing SystemCAC · Traditional | Harvest Technologies, LLC | 04/02/1999SE |
| K982660 | Orthopedic Perioperative Autotransfusion (Orthopat) SystemCAC · Traditional | Transfusion Technologies Corp. | 03/30/1999SE |
| K984233 | C.A.T.S Autotransfusion Accessories, Models Ats Suction Line, Aty Y-Adapter, and Ato…CAC · Traditional | Fresenius Hemotechnology, Inc. | 02/01/1999SE |
| K982712 | Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250CAC · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 12/18/1998SE |
| K982650 | Autologous Blood Management System (Abms)CAC · Abbreviated | Dideco S.P.A. | 12/16/1998SE |
| K982241 | Betatrans Intraop I and II Model Numbers DS100X and DS10XXCAC · Traditional | Duxbury Scientific, Inc. | 11/30/1998SE |
| K982755 | Modification of Autotransfusion Apparatus (Autolog)CAC · Traditional | Medtronic Blood Management | 08/20/1998SE |
| K972894 | Autotransfusion Appartus (Autolog)CAC · Traditional | Medtronic Blood Management | 04/27/1998SE |
| K974897 | Cobe Brat 2 System with Modified Standard Volume Processing SetCAC · Traditional | Cobe Cardiovascular, Inc. | 03/31/1998SE |
| K963759 | Dideco Compact-A and Compact-M Autotransfusion SystemsCAC · Traditional | Sorin Biomedical, Inc. | 02/20/1998SE |
| K963758 | Code 150 Blood Component Collection Set and with Direct Draw LineCAC · Traditional | Sorin Biomedical, Inc. | 02/20/1998SE |
| K970714 | Stryker Constavac Blood Conservation System II (Cbcii)CAC · Traditional | Stryker Instruments | 12/16/1997SE |
| K970857 | Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle…CAC · Traditional | Davis & Geck, Inc. | 11/05/1997SE |
| K973627 | Standard Volume Processing Set for the Cobe Brat 2 Autologous Blood Salvage SystemCAC · Traditional | Cobe Cardiovascular, Inc. | 11/03/1997SE |
| K973378 | C.A.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model…CAC · Traditional | Fresenius USA, Inc. | 11/03/1997SE |
| K971274 | C.A.T.S Continuous Autotransfusion System, AT1 Autotransfusion Set, PSQ SetCAC · Traditional | Fresenius AG | 06/13/1997SE |
| K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemCAC · Traditional | Deknatel, Inc. | 04/22/1997SE |
| K962475 | Orthopedic Perioperative Autotransfusion (Orthopat) SystemCAC · Traditional | Transfusion Technologies Corp. | 02/20/1997SE |
| K962689 | Cobe Brat 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP)CAC · Traditional | Cobe Cardiovascular, Inc. | 01/28/1997SE |
| K964070 | Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery BagCAC · Traditional | Deknatel, Inc. | 12/31/1996SE |
| K960734 | Haemocell System 350 or S350CAC · Traditional | Haemocell Plc | 12/10/1996SE |
| K963098 | Pleur-Evac Shara Plus Model S-2150/CONTINUOUS Reinfusion Autotransfusion SYSTEM(S-100)CAC · Traditional | Deknatel, Inc. | 11/08/1996SE |
| K960006 | C.A.T.S. Continuous Autotransfusion SystemCAC · Traditional | Fresenius AG | 07/31/1996SE |
| K955010 | Autovac BP Syste, 2000 SeriesCAC · Traditional | Boehringer Laboratories | 06/20/1996SE |
| K942844 | Level 1 Blood Stream Recovery SystemCAC · Traditional | Level 1 Technologies, Inc. | 04/26/1996SE |
| K951592 | Betatrans I and IICAC · Traditional | Duxbury Scientific, Inc. | 03/04/1996SE |
| K953118 | CaracellCAC · Traditional | Medtronic Vascular | 02/23/1996SE |
| K952224 | Stryker Constavac Blood Conservation System II (Cbcii)CAC · Traditional | Stryker Instruments | 11/17/1995SE |
| K945775 | Boehringer Autovac(R) 7900 SeriesCAC · Traditional | Boehringer Laboratories | 10/19/1995SE |
| K944232 | Autoflo Intra-Op Shed Blood Autortransfustion SysCAC · Traditional | Haemonetics Corp. | 07/20/1995SE |
| K942791 | Argyle Aqua-Seal Continuous Autotransfusion Chest Drainage UnitCAC · Traditional | Sherwood Medical Co. | 05/10/1995SE |
| K936220 | Dideco Vacuum PumpCAC · Traditional | Dideco | 01/27/1995SE |
| K940519 | Dideco Compact-A Autotransfusion SystemCAC · Traditional | Dideco | 01/19/1995SE |
| K931899 | Davol AtsCAC · Traditional | Davol, Inc. | 11/15/1994SE |
| K926338 | Pleur-Evac Cardiotomy Reservoir # CR-9400 & 9400FCAC · Traditional | Deknatel, Inc. | 07/26/1994SE |
| K932093 | Autovac Closed Wound Autotransfusion SYSTEM,7920 SCAC · Traditional | Boehringer Laboratories | 07/06/1994SE |
| K933960 | Plasma Recovery Program for the Cobe Brat 2 Autologous Blood Salvage SystemCAC · Traditional | Cobe Cardiovascular, Inc. | 06/10/1994SE |
| K940678 | Autotransfusion Suction Reservoir with FilterCAC · Traditional | Baxter Healthcare Corp | 04/15/1994SE |
| K932890 | Cell Saver 5 SystemCAC · Traditional | Haemonetics Corp. | 01/05/1994SE |
| K933625 | Brat 2 Autologus Blood Salvage SystemCAC · Traditional | Cobe Cardiovascular, Inc. | 12/29/1993SE |
| K931552 | Davol Cardiovascular Autotransfusion UnitCAC · Traditional | Davol, Inc. | 10/08/1993SE |
| K931106 | Biosurge(Tm) Synchronous Autotrans Procedure KitCAC · Traditional | Deknatel, Inc. | 10/06/1993SE |
| K925827 | Impraflo(Tm) Post Operative/Drain/Reinfus Kit/CaniCAC · Traditional | Impra, Inc. | 07/29/1993SE |
| K920618 | Autotransfusion Suction SetCAC · Traditional | Lifestream Int'L, Inc. | 03/12/1993SE |
| K913247 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | Solco Basle, Inc. | 02/25/1993SE |
| K913177 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | Solco Basle, Inc. | 02/25/1993SE |
| K915130 | Mat Membrane Autotransfusion SystemCAC · Traditional | Estracorporeal, Inc. | 02/22/1993SE |
| K924894 | Autovac 7900 SeriesCAC · Traditional | Boehringer Laboratories | 02/05/1993SE |
| K920273 | Hemovac Autotransfusion SystemCAC · Traditional | Zimmer Patient Care Division | 01/28/1993SE |
| K914119 | Davol Orthopaedic Autotransfusion SystemCAC · Traditional | Davol, Inc. | 12/03/1992SE |
| K923016 | Autologous Blood Collection SetCAC · Traditional | Advanced Haemotechnologies | 11/23/1992SE |
| K914053 | System 350CAC · Traditional | Stryker Corp. | 09/25/1992SE |
| K913181 | Autologous Blood Processing SystemCAC · Traditional | Lifestream Int'L, Inc. | 05/20/1992SE |
| K913773 | Cobe Brat Systems Without Reinfusion ProtectionCAC · Traditional | Cobe Cardiovascular, Inc. | 01/27/1992SE |
| K912956 | Atrium Dual Ats Water Seal Chest Drain UnitCAC · Traditional | Atrium Medical Corp. | 11/29/1991SE |
| K912610 | Mini-Op Ats Blood Recovery Bag, Model 2955CAC · Traditional | Atrium Medical Corp. | 11/29/1991SE |
| K912609 | Mini-Op Ats Blood Recovery Bag, Moel 2950CAC · Traditional | Atrium Medical Corp. | 11/29/1991SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | Shiley, Inc. | 11/27/1991SE |
| K913684 | Davol Post-Op Autotransfusion SystemCAC · Traditional | Davol, Inc. | 11/15/1991SE |
| K912019 | Orthofuser Wound Drainage/Autotransfusion SystemCAC · Traditional | Gish Biomedical, Inc. | 10/08/1991SE |
| K904164 | Autovac (R) Autotransfusion System, 7900 ModifiedCAC · Traditional | Boehringer Laboratories | 09/06/1991SE |
| K911656 | Pleur-Evac Plus Contin. Reinfus. & Autoinfus. SystCAC · Traditional | Pfizer Hospital Products Group, Inc. | 08/13/1991SE |
| K910238 | Portable Auto Transfusion System 500CAC · Traditional | Electromedics, Inc. | 06/19/1991SE |
| K910211 | Orth-Evac(Tm) Suction Hand Bulb Model No. 01-150CAC · Traditional | Deknatel, Inc. | 04/03/1991SE |
| K904888 | Autowand(Tm) 7XXX Series, ModificationCAC · Traditional | Boehringer Laboratories | 01/16/1991SE |
| K904794 | In-Line Ats Blood Recovery BagCAC · Traditional | Atrium Medical Corp. | 01/08/1991SE |
| K904515 | Impraflo 3500 SeriesCAC · Traditional | Impra, Inc. | 12/04/1990SE |
| K904474 | Haemonetics LN 200F Collection ReservoirCAC · Traditional | Haemonetics Corp. | 11/13/1990SE |
| K904041 | Haemonetics Cell Saver 4 PlusCAC · Traditional | Haemonetics Corp. | 11/13/1990SE |
| K901401 | Davol Autotransfusion Blood Processing SystemCAC · Traditional | Davol, Inc. | 10/23/1990SE |
| K903392 | Electromedics BT422-120 and BT422-40CAC · Traditional | Electromedics, Inc. | 09/06/1990SE |
| K900483 | Varidyne at Postoperative Orthopedic Autotransfu.CAC · Traditional | Baxter Healthcare Corp | 08/29/1990SE |
| K902713 | Access. Kit for the Biosurge Synchronous AutotransCAC · Traditional | Diemolding Corp. | 07/25/1990SE |
| K902059 | Autowand(Tm) 7XXX SeriesCAC · Traditional | Boehringer Laboratories | 07/24/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | Cobe Laboratories, Inc. | 07/18/1990SE |
| K901232 | Impraflo Autotransfusion DeviceCAC · Traditional | Impra, Inc. | 07/18/1990SE |
| K902671 | Cobe Autologous Blood Salvage Reserv W/W/O FilterCAC · Traditional | Cobe Laboratories, Inc. | 07/17/1990SE |
| K900325 | Orth-Evac TMCAC · Traditional | Deknatel, Inc. | 07/03/1990SE |
| K901138 | Autovac(R) Autotransfusion System, 7900 SeriesCAC · Traditional | Boehringer Laboratories | 06/18/1990SE |
| K893218 | AP900/PRP Module and Accessories, ModificationCAC · Traditional | Electromedics, Inc. | 06/12/1990SE |
| K900299 | Ats Y Adapter Code #2452CAC · Traditional | Artium Medical Corp. | 05/01/1990SE |
| K896858 | Solcotrans Intraoperative Autotransfusion SystemCAC · Traditional | Solco Basle, Inc. | 04/05/1990SE |
| K896857 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | Solco Basle, Inc. | 04/05/1990SE |
| K897127 | Atrium 2052 Chest Drain, Dual Collection BloodCAC · Traditional | Atrium Medical Corp. | 03/13/1990SE |
| K897126 | Atrium 2050 Chest Drain Blood Recovery SystemCAC · Traditional | Atrium Medical Corp. | 03/13/1990SE |
| K895297 | Autotransfusion Reservior Model 7900 ModificationCAC · Traditional | Boehringer Laboratories | 03/13/1990SE |
| K892443 | Blood Recovery/Autotransfusion Reservoir ATR-2900CAC · Traditional | Gish Biomedical, Inc. | 11/08/1989SE |
| K894668 | Modified Shiley Therapeutic Autotransfusion SystemCAC · Traditional | Shiley, Inc. | 10/20/1989SE |
| K893394 | Orthopedic Wound Drainage Set with TrocarCAC · Traditional | Haemonetics Corp. | 10/19/1989SE |
| K894294 | Dideco-Shiley Universal YCAC · Traditional | Shiley, Inc. | 08/15/1989SE |
| K893578 | Pharmaseal Medi-Vac Sterile Post-Op Autotrans. SysCAC · Traditional | Baxter Healthcare Corp | 08/01/1989SE |
| K893402 | Compact 2052(TM) Dual Collection Blood RecoveryCAC · Traditional | Atrium Medical Corp. | 06/23/1989SE |
| K892857 | Harvesting TubeCAC · Traditional | Conmedcorp | 06/15/1989SE |
| K890171 | Inline Autotransfusion SystemCAC · Traditional | Conmedcorp | 06/15/1989SE |
| K892819 | Autotransfusion DeviceCAC · Traditional | Impra, Inc. | 05/22/1989SE |
| K884564 | Shiley Therapeutic Autotransfusion System-ProgrammCAC · Traditional | Shiley, Inc. | 05/05/1989SE |
| K884844 | Pleur-Evac(R) A-7002--ADULT/PEDIATRIC DrainageCAC · Traditional | Deknatel, Inc. | 01/24/1989SE |
| K883934 | Cell Saver Haemolite B Auto. Blood Recovery SystemCAC · Traditional | Haemonetics Corp. | 12/27/1988SE |
| K883058 | Solcotrans Ortho. Drainage/Reinfusion SystemCAC · Traditional | Solco Basle, Inc. | 10/28/1988SE |
| K883082 | PLEUR-EVAC(R)-A-7020-INFANT Chest Drain SystemCAC · Traditional | Deknatel, Inc. | 10/13/1988SE |
| K883663 | Ats Blood Recovery BagCAC · Traditional | Atrium Medical Corp. | 09/30/1988SE |
| K881350 | Cbc/Constavac Blood Conservation SystemCAC · Traditional | Stryker Corp. | 09/30/1988SE |
| K881631 | Biodynamics Autotransfusion ReservoirCAC · Traditional | Biodynamics Corp. | 09/09/1988SE |
| K882757 | Argyle Autotransfusion BagCAC · Traditional | Sherwood Medical Co. | 09/01/1988SE |
| K881692 | Dideco-Shiley Fluid Collection BagCAC · Traditional | Shiley, Inc. | 07/08/1988SE |
| K881683 | Dideco-Shiley Autotrans BT 795/AACAC · Traditional | Shiley, Inc. | 06/27/1988SE |
| K881129 | Auto-Vac Intraoperative Autotrans. Reservoir #7904CAC · Traditional | Boehringer Laboratories | 06/14/1988SE |
| K881421 | Dideco-Shiley Feed Tube Support Arms and HookCAC · Traditional | Shiley, Inc. | 05/04/1988SE |
| K880162 | PLEUR-EVAC--A-5002 Chest Drainage System W/AutoCAC · Traditional | Deknatel, Inc. | 03/21/1988SE |
| K873807 | Autotransfusion ApparatusCAC · Traditional | Biodynamics Corp. | 03/09/1988SE |
| K875023 | Biosurge Model Oasys-IiCAC · Traditional | Biosurge, Inc. | 02/12/1988SE |
| K872927 | Davol Intraoperative Autotransfusion KitCAC · Traditional | C.R. Bard, Inc. | 10/09/1987SE |
| K872590 | Solcotrans Chest Drainage Autotransfusion SystemCAC · Traditional | Solco Basle, Inc. | 09/04/1987SE |
| K872814 | Shiley Therapeutic Autotransfusion System (Remote)CAC · Traditional | Shiley, Inc. | 08/05/1987SE |
| K872160 | Dideco-Shiley Blood Separation Wash BowlCAC · Traditional | Shiley, Inc. | 07/24/1987SE |
| K872162 | Dideco-Shiley Blood Reinfusion BagCAC · Traditional | Shiley, Inc. | 07/21/1987SE |
| K872158 | Dideco-Shiley Waste Collection BagCAC · Traditional | Shiley, Inc. | 07/21/1987SE |
| K871624 | Thora-Drain(R) Abt SystemCAC · Traditional | Sherwood Medical Co. | 06/22/1987SE |
| K871568 | Pleura-Gard AtsCAC · Traditional | Conmedcorp | 06/22/1987SE |
| K871847 | BT-795/ATSCAC · Traditional | Electromedics, Inc. | 06/19/1987SE |
| K871258 | Biosurge Model OasysCAC · Traditional | Biosurge, Inc. | 05/21/1987SE |
| K864374 | Argyle Sentinel Seal Autotransfusion SystemCAC · Traditional | Sherwood Medical Co. | 03/16/1987SE |
| K862684 | Auto-Vac (TM) Autotransfusion Reserv, Model 7900CAC · Traditional | Boehringer Laboratories | 10/17/1986SE |
| K861677 | Pharmaseal Medi-Vac Intra-Oper. Autotransfus. KitCAC · Traditional | American Pharmaseal Div. Ahsc | 06/16/1986SE |
| K860306 | BT-795/P Automated AutotransCAC · Traditional | Electromedics, Inc. | 03/06/1986SE |
| K852178 | Exu-Bag CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOSCAC · Traditional | American Omni Medical, Inc. | 12/27/1985SE |
| K854301 | Pleur-Evac II Autotransfusion SystemCAC · Traditional | Deknatel, Inc. | 11/19/1985SE |
| K843821 | Solco Basle Intraoperative AutottrnsfusCAC · Traditional | Solco Basle, Inc. | 10/01/1985SE |
| K852736 | Baylor Rapid Autotransfusion SystemCAC · Traditional | Cardio Systems, Inc. | 09/18/1985SE |
| K852425 | Cell Saver Suction SystemCAC · Traditional | Haemonetics Corp. | 09/03/1985SE |
| K851024 | Pleur-Evac Autotransfusion System -TentativeCAC · Traditional | Pfizer, Inc. | 05/23/1985SE |
| K842610 | Guidelines for Pediatric AnesthesiaCAC · Traditional | Critical Care Micro Computing | 10/04/1984SE |
| K831849 | Pleural Drainage Sys #PDS-100-4CAC · Traditional | American Bentley | 12/29/1983SE |
| K831557 | Intraoperative Autotransfusion SysCAC · Traditional | Thoratec Laboratories Corp. | 08/24/1983SE |
| K830735 | BT 795/A AutotransCAC · Traditional | Electromedics, Inc. | 05/02/1983SE |
| K812292 | Autotrans BT795CAC · Traditional | Electromedics, Inc. | 10/23/1981SE |
| K812355 | IBM 2991 Blood Cell Processor Mod. 1 & 2CAC · Traditional | Intl. Business Machines | 09/09/1981SE |
| K811228 | Sorenson Catalog #IFL-120SCAC · Traditional | Sorensen Research | 06/09/1981SE |
| K802674 | Reservoir for Autologous Blood Transfus.CAC · Traditional | Haemonetics Corp. | 01/08/1981SE |
| K791891 | Acu-Med Red Miser Hemothorax Blood Coll.CAC · Traditional | Acumed Instruments Corp. | 12/05/1979SE |
| K781553 | Mediastinal Drainage Tube Set MDT-36TC2CAC · Traditional | Sorensen Research | 10/26/1978SE |
| K781552 | Mediastinal Drainage Tube Set MDT-32TC2CAC · Traditional | Sorensen Research | 10/26/1978SE |
| K781551 | Trauma Drainage Set 72T-32TTCCAC · Traditional | Sorensen Research | 10/26/1978SE |
| K781550 | Trauma Drainage Set 72T-28TTCCAC · Traditional | Sorensen Research | 10/26/1978SE |
| K772280 | Receptal Ats Mediastinal LinerCAC · Traditional | Sorensen Research | 01/03/1978SE |
| K772196 | Receptal Ats Trauma KGA1900LCAC · Traditional | Sorensen Research | 12/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0710-2024 Class I | Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery UnitExpress chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is… | Maquet Cardiovascular, LLC | 12/13/2023Open, Classified |
| Z-0709-2024 Class I | Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single CollectionExpress chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is… | Maquet Cardiovascular, LLC | 12/13/2023Open, Classified |
| Z-0621-2024 Class II | Atrium Oasis Drain Single W / AC, Part No. 3600-100A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date… | Atrium Medical Corporation | 11/01/2023Open, Classified |
| Z-0318-2024 Class II | Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N…Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient… | Atrium Medical Corporation | 09/18/2023Open, Classified |
| Z-0317-2024 Class II | Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC…Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient… | Atrium Medical Corporation | 09/18/2023Open, Classified |
| Z-0316-2024 Class II | Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000…Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient… | Atrium Medical Corporation | 09/18/2023Open, Classified |
| Z-0486-2024 Class II | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU…Product was re-processed and re-sterilized by a third party using packaging configurations and a… | Atrium Medical Corporation | 09/05/2023Open, Classified |
| Z-0906-2020 Class II | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0905-2020 Class II | Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0904-2020 Class II | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0903-2020 Class II | JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0902-2020 Class II | JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0901-2020 Class II | Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0900-2020 Class II | JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0899-2020 Class II | JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0898-2020 Class II | JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0897-2020 Class II | JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0896-2020 Class II | CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0895-2020 Class II | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0894-2020 Class II | CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0893-2020 Class II | CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0892-2020 Class II | CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0891-2020 Class II | Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0890-2020 Class II | CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0889-2020 Class II | CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0888-2020 Class II | CS5/5+ Fastpacks, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0887-2020 Class II | High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0886-2020 Class II | CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-0885-2020 Class II | CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related…Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml… | Haemonetics Corporation | 10/21/2019Terminated |
| Z-1209-2019 Class II | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the…Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the… | Fenwal Inc | 03/05/2019Terminated |
| Z-1059-2019 Class II | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion…The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. | Fenwal Inc | 02/11/2019Terminated |
| Z-0786-2019 Class II | SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation…Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and… | Medtronic Perfusion Systems | 11/27/2018Open, Classified |
| Z-0785-2019 Class II | RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are…Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and… | Medtronic Perfusion Systems | 11/27/2018Open, Classified |
| Z-2951-2018 Class II | Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The…OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the… | Haemonetics Corporation | 07/13/2018Terminated |
| Z-2950-2018 Class II | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic…OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the… | Haemonetics Corporation | 07/13/2018Terminated |
| Z-0779-2019 Class II | Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The…Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell… | Haemonetics Corporation | 08/02/2017Terminated |
| Z-0778-2019 Class II | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The…Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell… | Haemonetics Corporation | 08/02/2017Terminated |
| Z-1211-2017 Class II | Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-1208-2017 Class II | Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-1207-2017 Class II | Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference:…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-1582-2016 Class II | Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx…The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and… | Teleflex Medical | 03/30/2016Terminated |
| Z-1573-2015 Class II | Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1572-2015 Class II | 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1571-2015 Class II | 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1570-2015 Class II | 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | Stryker Instruments Div. of Stryker… | 03/26/2015Terminated |
| Z-1959-2014 Class II | Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N.…Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or… | Atrium Medical Corporation | 04/28/2014Terminated |
| Z-0743-2014 Class II | Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | Atrium Medical Corporation | 11/19/2013Terminated |
| Z-0742-2014 Class II | Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | Atrium Medical Corporation | 11/19/2013Terminated |
| Z-0741-2014 Class II | Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | Atrium Medical Corporation | 11/19/2013Terminated |
| Z-0740-2014 Class II | Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest…Chest Drain tubing of of the ATS Blood recovery may leak or disconnect | Atrium Medical Corporation | 11/19/2013Terminated |