FDAFDA · Food and drugs·Recall number Z-0195-2016
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Published November 11, 2015 · Recall initiated: September 21, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Alcon Research, Ltd.
- Distributor
- Distributed in VT.
- Lot
- 1792733H, 1783925H, 1785227H, 1786729H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.