Reported Apr 14, 2021 · Terminated
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Fenwal 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: Fenwal Inc · 3 Corporate Dr Ste 300 · Lake Zurich, IL · 60047-8930
Is this the product you have?
- Amicus Exchange Kit - Product Usageintended for use in the collection of blood components and mononuclear cells
- Lot codes and dates
- Product Code X6R2339
- UDI
04086000100151Batch Numbers FA20F08147 (Exp. 06/07/2022)FA20H12145 (Exp. 08/11/2022)FA20J27157 (Exp. 10/26/2022)
- Amount recalled
- 2466 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
This product could cause temporary or reversible health problems — stop using it.
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