Windstone Medical Packaging, Inc. — Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
⚠️ 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).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 11, 2026
US Nationwide distribution in the states of GA, OR, TN, and WA.
What's affected?
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Lot code
- 220039
Additional details
UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 380 units.
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