FDAMarch 11, 2026device

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

Official recall recorded by the U.S. Food & Drug Administration.

The 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).

What to do

FDA enforcement status: Ongoing

Brands named

windstone medical packagingwindstonewindstone medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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