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. Component of Amicus Separator Recalled by Fenwal Inc Due to Potential for centrifuge packs to develop a stress...
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. Component of Amicus Separator multiprocedural apheresis platform
Quantity: 1,614 units
Why Was This 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.
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