Custom Convenience Kits Pre Op Kit — Class II medical device recall Z-1919-2026
Ongoing recall by Windstone Medical Packaging, Inc., reported 2026-04-29, distributed nationwide. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction f
| Recall number | Z-1919-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2026-03-11 |
| Classified | 2026-04-22 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 475 units |
| Reason classes | device malfunction |
| Lot numbers | 204612, 206723, 210211, 213641, 216064, 222060, 224073, 225012, 236012, 236910 |
| Model numbers | AMS14433 |
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Reason for recall
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
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-1919-2026. 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.