Reported Jun 21, 2017 · Terminated
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage:…
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?
- OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide
- gas in peel-open packages Product UsageUsed with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
- Lot codes and dates
- OptiLite Multi-Use Holmium Laser Fibers
- Catalog Numbers followed by GPN
HLF-M273-CNVG48611 HLF-M273-SMAG48522 HLF-M365-CNVG48613 HLF-M365-SMAG48618 HLF-M550-CNVG48615 HLF-M550-SMAG48619 HLF-M940-CNVG48617 HLF-M940-SMAG48621 HLF-M273-CNV-CANG51777 HLF-M273-SMA-CANG51785 HLF-M365-CNV-CANG51778 HLF-M365-SMA-CANG51786 HLF-M550-CNV-CANG51779 HLF-M550-SMA-CANG51787 HLF-M940-CNV-CANG51780 HLF-M940-SMA-CANG51788
- Amount recalled
- 10,415
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
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cook Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.