Recall Z-0195-2016
Alcon Research, Ltd. · initiated September 21, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Codes / lots: 1792733H, 1783925H, 1785227H, 1786729H
Reason for recall
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
FDA-determined cause: Mixed-up of materials/components
Action taken
The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered.
Details
- Recall number
- Z-0195-2016
- Initiated
- September 21, 2015
- Posted by FDA
- October 30, 2015
- Terminated
- March 24, 2016
- Product code
- LRO – General Surgery Tray
- Quantity
- 5 units
- Distribution
- Distributed in VT.
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX