Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 11, 2026 |
| Reported | April 29, 2026 |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Country / region | United States MT |
Hazard
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).
Affected products
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Related recalls
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