Custom Pak 9319-27 — Class II medical device recall Z-0195-2016
Terminated recall by Alcon Research, Ltd., reported 2015-11-11, distributed in VT. The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified n
| Recall number | Z-0195-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2015-09-21 |
| Classified | 2015-10-30 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-03-24 |
| Distributed | VT |
| Quantity | 5 units |
| Reason classes | labeling |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0195-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.