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

Recall Z-0853-2013 — NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

U.S. FDA — Device Enforcement · United States · 2013-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0853-2013
Date of alert
2013-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Codman & Shurtleff, Inc.
Product category
device
Product type
Devices
Reported risk: Sterility of device may be compromised due to lack of package integrity
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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