Z-1921-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 520 units
Product Description
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
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).
Distribution Pattern
US Nationwide distribution in the states of GA, OR, TN, and WA.
Code Information
UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209