Recall Z-1920-2026— Windstone Medical Packaging, Inc.
Class II · Ongoing
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2026-03-11. FDA's recall record names no specific 510(k) clearance for this event. 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)..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-11
- Firm location
- Billings, MT, United States
Product description
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.