Reported Jun 21, 2017 · Terminated

Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

Cook Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Lot codes and dates
    • HLF-M273-H30
    • HLF-M365-H30
    • HLF-M550-H30
    • HLF-M940-H30
    • HLF-M273-HSMA
    • HLF-M365-HSMA
    • HLF-M550-HSMA
    • HLF-M940-HSMA
Amount recalled
4369

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 26, 2018 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.