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CLASS II · ModerateFDA

Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit

📅 Mar 11, 2026 · 📍 Nationwide
Recalling company
Windstone Medical Packaging, Inc.
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Reason
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 – may cause temporary or medically reversible health consequences
Recall date
Mar 11, 2026
Reported
Apr 29, 2026
Distribution
US Nationwide distribution in the states of GA, OR, TN, and WA.
Status
Ongoing
Quantity
380 units
Lot / codes
UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009
Company location
Billings, MT
Recall type
Voluntary: Firm initiated
Recall number
Z-1920-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1920-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.