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

Recall Z-2585-2017 — OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation

U.S. FDA — Device Enforcement · United States · 2017-05-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2585-2017
Date of alert: 2017-05-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cook Inc.
Product category: device
Product type: Devices

Reported risk: Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently 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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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