Class II — Windstone Medical Packaging, Inc.
| Recalling firm | WINDSTONE MEDICAL PACKAGING, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure |
| Quantity | 12 kits |
| Distribution | Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY. |
| Initiated | 2017-03-16 |
| Classified | 2017-04-11 |
| Terminated | 2017-06-06 |
| Recall number | Z-1795-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Windstone Medical Packaging, Inc. (Z-1795-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76774/
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