Reported Dec 28, 2016 · Terminated
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion…
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc · 710 Medtronic Pkwy · Minneapolis, MN · 55432-5603
Is this the product you have?
- Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
- Lot codes and dates
103 of 103 products
Products covered by this recall Model / number Barcodes Product as published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mount recalled
- 5609 (663 US; 4946 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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