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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 5 of 5 Results
510(K) Number: K012538
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Product Description
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Recall
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FDA Recall
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Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS... 3 02/26/2016 Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene ... 2 11/12/2015 Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72... 2 09/04/2015 Medtronic Perfusion Systems
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching hepari... 2 08/27/2013 Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda ... 2 12/28/2012 Medtronic Inc. Cardiac Rhythm Disease Management
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