Custom Pak 9319-27. Single-use medical devices and recall
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Why was Custom Pak 9319-27. Single-use medical devices and recalled?
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1792733H, 1783925H, 1785227H, 1786729H
- Product
- Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
- Recalling firm
- Alcon Research, Ltd.
- Quantity
- 5 units
- Distribution
- Distributed in VT.
- Recall date
- November 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)