FDA Device recall Z-0195-2016
Custom Pak 9319-27
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Custom Pak 9319-27 by Alcon Research, citing the recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0195-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-21 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alcon Research |
| Distribution | VT |
Product
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Reason
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
Identifiers
| code_info | 1792733H, 1783925H, 1785227H, 1786729H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0195-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.