Reported Nov 11, 2015 · Terminated
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific…
Alcon Research, Ltd.
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: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
- Lot codes and dates
1792733H1783925H1785227H1786729H
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
This product could cause temporary or reversible health problems — stop using it.
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