Reported Mar 24, 2021 · Terminated
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR)…
Medtronic Perfusion Systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 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 during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic
- NameCardiopulmonary bypass oxygenator)
- Lot codes and dates
- DescriptionCUSTOM PACK HY10J00R6 ECC SMALL CAR
- Model NumberHY10J00R6
- GTIN00763000304928
- Lot number220768819
- Amount recalled
- 3 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Using this product could cause serious injury, illness or death — stop using it now.
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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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