- Recalling firm
- Windstone Medical Packaging, Inc.
- 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).
- Affected products (lot / model / serial)
- UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009
- Units affected
- 380 units
- Distribution pattern
- US Nationwide distribution in the states of GA, OR, TN, and WA.
- Firm location
- Billings, MT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1920-2026
- Recall initiated
- March 11, 2026
- FDA classification date
- April 22, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98659
- Last updated on HTM Vibe
- July 24, 2026