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

Recall Z-2539-2017 — Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

U.S. FDA — Device Enforcement · United States · 2017-05-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2539-2017
Date of alert
2017-05-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
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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