Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalm
FDA device recall Z-0195-2016 · posted 2015-10-30 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- 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.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 5 units
- Distribution
- Distributed in VT.
- Date initiated
- 2015-09-21
- Date posted
- 2015-10-30
- Date terminated
- 2016-03-24
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON SURGICAL PROCEDURE PACKS (K880961) | Alcon Laboratories | 1988-04-29 |