Product Wiki · Recalls · U.S. FDA — Device Enforcement

Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform — recall Z-1254-2023

U.S. FDA — Device Enforcement · United States · 2023-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1254-2023
Date of alert
2023-02-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fenwal Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04086000100144
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.