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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 10 Results
510(K) Number: K183511
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Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosur... 1 03/17/2021 Medtronic Perfusion Systems
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance ... 1 03/17/2021 Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous... 1 03/17/2021 Medtronic Perfusion Systems
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Af... 1 03/17/2021 Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reser... 1 03/17/2021 Medtronic Perfusion Systems
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy... 1 03/17/2021 Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir... 1 03/17/2021 Medtronic Perfusion Systems
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixi... 1 03/17/2021 Medtronic Perfusion Systems
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Card... 1 03/17/2021 Medtronic Perfusion Systems
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Card... 1 03/17/2021 Medtronic Perfusion Systems
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