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

Recall Z-0977-2020 — Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888

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-0977-2020
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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