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Windstone Medical Packaging, Inc.: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Medical DevicesSource: FDA (device) · Date: 2026-04-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Windstone Medical Packaging, Inc.
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Reason / 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).
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of GA, OR, TN, and WA.
Recall initiated
2026-03-11
Code info
UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
Product quantity
520 units
Voluntary mandated
Voluntary: Firm initiated
City
Billings
State
MT
Country
United States
Event id
98659
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