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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-1195-2021 - Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and stor... 1 03/17/2021 Medtronic Perfusion Systems
Z-1193-2021 - Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device desig... 1 03/17/2021 Medtronic Perfusion Systems
Z-1194-2021 - Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect an... 1 03/17/2021 Medtronic Perfusion Systems
Z-1197-2021 - Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to coll... 1 03/17/2021 Medtronic Perfusion Systems
Z-1198-2021 - Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect an... 1 03/17/2021 Medtronic Perfusion Systems
Z-1190-2021 - Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CV... 1 03/17/2021 Medtronic Perfusion Systems
Z-1191-2021 - Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir ... 1 03/17/2021 Medtronic Perfusion Systems
Z-1192-2021 - Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood... 1 03/17/2021 Medtronic Perfusion Systems
Z-1199-2021 - Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood durin... 1 03/17/2021 Medtronic Perfusion Systems
Z-1196-2021 - Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during ex... 1 03/17/2021 Medtronic Perfusion Systems
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