Custom Convenience Kits Pre Op Kit - NS recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIOngoing
Summary: Windstone Medical Packaging, Inc. is recalling Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A. 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).
What is being recalled
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Why
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).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of GA, OR, TN, and WA. (states named: Georgia, Oregon, Tennessee, Washington)
How to tell if yours is affected
UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1921-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 11, 2026 |
| Reported | April 29, 2026 |
| Company | Windstone Medical Packaging, Inc. |
| Company location | Billings, MT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 520 units |
More recalls from Windstone Medical Packaging, Inc. · all medical device recalls · recalls from March 2026