Recall
FDAHealthMarch 11, 2026

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.

View original FDA notice →

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