Windstone Medical Packaging, Inc. — Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
⚠️ 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 AMS14433
- Lot code
- 204612
Additional details
UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 475 units.
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