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 | Ongoing |
| Reason | The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation. |
| Product | AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B |
| Quantity | 3,260 kits |
| Distribution | US Nationwide distribution in the states of CA, GA, WA. |
| Initiated | 2026-07-29 |
| Classified | 2026-09-10 |
| Recall number | Z-3138-2026 |
| 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 II recall — Windstone Medical Packaging, Inc. (Z-3138-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99658/
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