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

Recall Z-1687-2020 — GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

U.S. FDA — Device Enforcement · United States · 2020-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1687-2020
Date of alert
2020-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Reported risk: The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
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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