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

Recall Z-1250-2017 — GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

U.S. FDA — Device Enforcement · United States · 2017-01-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1250-2017
Date of alert
2017-01-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Vascular Solutions, Inc.
Product category
device
Product type
Devices
Reported risk: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
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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