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

Recall Z-1344-2021 — Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

U.S. FDA — Device Enforcement · United States · 2021-02-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1344-2021
Date of alert
2021-02-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fenwal Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04086000100151
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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