Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Reported: November 11, 2015 Initiated: September 21, 2015 #Z-0195-2016
Product Description
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
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.
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 5 units
- Distribution
- Distributed in VT.
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.. Recalled by Alcon Research, Ltd.. Units affected: 5 units.
Why was this product recalled? ▼
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0195-2016.
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