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 | These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal. |
| Product | General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges. |
| Quantity | 170 units |
| Distribution | Nationwide distribution to Louisiana and Montana. |
| Initiated | 2016-03-21 |
| Classified | 2016-06-01 |
| Terminated | 2016-08-16 |
| Recall number | Z-1870-2016 |
| 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-1870-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73743/
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