Reported Feb 8, 2023 · Ongoing
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance…
Medtronic Perfusion Systems
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 Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
- Lot codes and dates
- Oxygenator Model CB811
- Serial Number Range8111483548 - 8113999999; GTIN Number
- Tubing Pack Model Number (Lot Numbers)
944 of 944 codes
00643169505322HY2Q32R9 (223366543224282023)00643169572263HY8L55R5 (222887140223145744223145745223283258223323300223685612223685613223685614223860888223860889224043160224327270224327271224454137224623800224623801224659584224838251224838252224838253225126458)00643169618312HY7S51R10 (223235000224155208224454025224794488224861211)00643169661295HY8M65R2 (224539804)00643169713406HY7V67R9 (223247291224112023224752769)00643169724310HY8S40R2 (222974852223196617223196618223810224223810366224282014224497799224497800225047871225047872)00643169771260M530636A (223439641223775523224138283224695541225162264225415719)00643169792180M274404N (223260993224168527224567881224865204
- Amount recalled
- 40,498 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
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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