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U.S. Department of Health and Human Services

Medical Device Recalls
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CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def... 1 09/20/2024 Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def... 1 09/20/2024 Datascope Corp.
VACUETTE® TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged 2 07/17/2024 Greiner Bio-One North America, Inc.
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, no... 2 01/16/2024 Greiner Bio-One North America, Inc.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, ... 2 08/31/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, ... 1 08/30/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, ... 1 08/30/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, ... 1 08/30/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, ... 1 08/30/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83... 1 07/20/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83... 1 07/19/2023 Datascope Corp.
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 5... 2 05/12/2023 Greiner Bio-One North America, Inc.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-... 1 03/09/2023 Datascope Corp.
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 1 03/09/2023 Datascope Corp.
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 2 03/06/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, ... 2 03/06/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, ... 1 01/19/2023 Datascope Corp.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged... 2 01/18/2022 Greiner Bio-One North America, Inc.
Cardiosave Rescue IntraAortic Balloon Pump. Model UDI 0998-00-0800-75 1060756711... 1 12/30/2021 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 099... 2 10/07/2021 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 099... 2 09/30/2021 Datascope Corp.
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged 2 09/24/2021 Greiner Bio-One North America, Inc.
Greiner Bio-One VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, s... 2 09/22/2021 Greiner Bio-One North America, Inc.
VACUETTE® Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandw... 2 05/06/2021 Greiner Bio-One North America, Inc.
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provid... 3 04/28/2021 Datascope Corp.
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance... 2 03/12/2021 Medline Industries Inc
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are use... 2 09/29/2020 Greiner Bio-One North America, Inc.
VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blo... 2 05/26/2020 C.A. Greiner & Sohne Gesellschaftmbh
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. 2 04/15/2020 Greiner Bio-One North America, Inc.
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Hold... 2 01/17/2020 Greiner Bio-One North America, Inc.
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Resc... 2 12/09/2019 Bellus Medical
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use. 1 07/16/2019 Datascope Corp.
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to def... 2 07/03/2019 ZOLL Medical Corporation
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003... 2 11/28/2018 EUROTROL INC
HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.... 2 11/28/2018 EUROTROL INC
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 1 10/27/2018 Maquet Datascope Corp - Cardiac Assist Division
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with... 2 02/22/2018 Philips Electronics North America Corporation
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with... 2 02/22/2018 Philips Electronics North America Corporation
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG... 2 06/22/2017 O-Two Medical Technologies, Inc.
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-seal... 2 05/23/2017 Innovasis, Inc
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion ... 2 03/02/2017 Maquet Datascope Corp - Cardiac Assist Division
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifelin... 2 07/06/2016 Lifeline First Aid LLC
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes cont... 2 06/07/2016 Greiner Bio-One North America, Inc.
Cardiosave Hybrid and rescue IABP 2 03/25/2016 Maquet Datascope Corp - Cardiac Assist Division
HemoCue® Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with ... 2 12/24/2014 Radiometer America Inc
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit... 2 10/21/2014 Ad-Tech Medical Instrument Corporation
HemoCue® Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Swe... 2 10/29/2013 HemoCue AB
HemoCue® Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitat... 2 10/25/2013 HemoCue AB
HemoCue® Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose... 2 09/11/2013 HemoCue AB
Vacuette Cellestis 1 ml QuantiFERON® TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. g... 2 02/26/2013 Cellestis Inc
 
 
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