Reported Mar 22, 2023 · Ongoing
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
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 Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Lot codes and dates
- Product Code X6R2349
- UDI04086000101950
- Batch Numbers
FA22E23138FA22F28168FA22G28018FA22H22225FA22J28062FA22K21065. The Lot
- number coding system is the followingFAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit
- Amount recalled
- 6,564 units
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
- Nationwide
Why it was recalled
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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