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

Recall Z-0963-2020 — Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

U.S. FDA — Device Enforcement · United States · 2019-01-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0963-2020
Date of alert
2019-01-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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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