Alcon Patient Care Kits Product Usage: A Patient Care Kit is an… — Class II medical device recall Z-1837-2017
Terminated recall by Alcon Research, Ltd., reported 2017-04-26, distributed nationwide. Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is p
| Recall number | Z-1837-2017 |
|---|---|
| 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 | 2017-03-27 |
| Classified | 2017-04-17 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 561,702 |
| Reason classes | sterility |
Product
Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
Reason for recall
Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.
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-1837-2017. 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.