FDA Medical devices recall ·
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A recall
- Recall number
- Z-1921-2026
- Date
- (initiated March 11, 2026)
- Company / brand
- Windstone Medical Packaging, Inc.
1602 4th Ave N, Billings, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 520 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
Distribution
US Nationwide distribution in the states of GA, OR, TN, and WA.
States: Georgia Oregon Tennessee Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1921-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.