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Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Class II
Recalling firm
Windstone Medical Packaging, Inc.
Reason for recall
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).
Distribution pattern
US Nationwide distribution in the states of GA, OR, TN, and WA.
State
MT
Status
Ongoing
Recall number
Z-1921-2026
Recall initiated
March 11, 2026
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