Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amicus MNC Apheresis Kit - Double Needle - Product Usage: Recalled by Fenwal Inc Due to Some lots of Amicus MNC Apheresis and Amicus...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fenwal Inc directly.
Affected Products
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Quantity: 4488 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fenwal Inc
Fenwal Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report