Class I — 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 I |
| Status | Ongoing |
| Reason | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. |
| Product | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit |
| Quantity | 1080 kits |
| Distribution | US Nationwide distribution in the states of PA, GA, CA, WA. |
| Initiated | 2026-05-21 |
| Classified | 2026-07-01 |
| Recall number | Z-2619-2026 |
| 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 I recall — Windstone Medical Packaging, Inc. (Z-2619-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99189/
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