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Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Recalled April 29, 2026 · FDA recall Z-1920-2026 · Windstone Medical Packaging
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). · FDA Class II
Units
380 units
Sold at
US Nationwide distribution in the states of GA, OR, TN, and WA.
Description
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).
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Manufacturer(s)
Windstone Medical Packaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →