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

Recall Z-1628-2016 — GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular recons

U.S. FDA — Device Enforcement · United States · 2016-04-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1628-2016
Date of alert: 2016-04-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corp.
Product category: device
Product type: Devices

Reported risk: Instructions for use booklet may puncture the outer Tyvek lid.

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.

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.

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