Ortho Basic Pack — Class II medical device recall Z-1795-2017
Terminated recall by Windstone Medical Packaging, Inc., reported 2017-04-19, distributed nationwide. AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile
| Recall number | Z-1795-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2017-03-16 |
| Classified | 2017-04-11 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-06-06 |
| Distributed | Nationwide (US) |
| Quantity | 12 kits |
| Reason classes | sterility |
| Lot numbers | 101180 |
| Model numbers | AMS6459 |
Product
Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
Reason for recall
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad 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-1795-2017. 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.