Recall archive / FDA device enforcement
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In... — FDA record Z-0661-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 CARESITE, 140 IN; Catalog Number: 490309.
- Reason
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Classification
- Class II
- Recalling firm
- B Braun Medical Inc
- Quantity
- 259,392 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0661-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1. Catalog Number: 490309; Primary UDI-DI: 04046964527517; Unit of Dose UDI-DI: 04046964527500. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 3, 2025
- Recall initiation date
- Oct 29, 2025
- Center classification date
- Nov 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.