Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component… — Class II medical device recall Z-1947-2014
Terminated recall by Alcon Research, Ltd., reported 2014-07-09, distributed nationwide. Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains
| Recall number | Z-1947-2014 |
|---|---|
| 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 | 2014-05-16 |
| Classified | 2014-06-30 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2014-12-09 |
| Distributed | Nationwide (US) |
| Lot numbers | 1577346H, 1580492H, 1580988H, 1584114H, 1585992H, 1589608H, 1595079H |
| Model numbers | 585006 |
Product
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Reason for recall
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
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-1947-2014. 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.