Z-1920-2026 Class II Ongoing
FDA device recall Z-1920-2026 was initiated by Windstone Medical Packaging, Inc. on March 11, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 380 units.
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
- 380 units
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).
Distribution Pattern
US Nationwide distribution in the states of GA, OR, TN, and WA.
Code Information
UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009