Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI
Pending LLM rewrite. Source: FDA_DEVICE Z-0640-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
The recalled product
- Product
- Infusomat 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 numbers: 1. UNIV.15DROP PUMP SET W/3 SAFELINE LL;
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Catalog Number: 362032
- Primary UDI-DI: 04046964182556
- Primary UDI-DI: 04046964837821
- Primary UDI-DI: 04046964182570
- Primary UDI-DI: 04046964182631
- Primary UDI-DI: 04046964182655
- Primary UDI-DI: 04046955592715
- Primary UDI-DI: 04046964294013
- Primary UDI-DI: 04046964182679
- Primary UDI-DI: 04046964294174
- Primary UDI-DI: 04046964294198
- Primary UDI-DI: 04046964294259
- Primary UDI-DI: 04046964294495
- Primary UDI-DI: 04046964294570
- Primary UDI-DI: 04046964294594
- Primary UDI-DI: 04046964294617
- Primary UDI-DI: 04046964294631
- Primary UDI-DI: 04046964294655
- Primary UDI-DI: 04046964837906
- Primary UDI-DI: 04046964294679
Distribution
Distribution scope not specified by the agency.
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