[pending] IV Administration Set utilized in gravity IV administration sets and pump administration sets utiliz
Pending LLM rewrite. Source: FDA_DEVICE Z-0673-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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
- 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, 15DR, CARESIT
- 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 (7)
- 1. Catalog Number: 490522
- Primary UDI-DI: 04046955203123
- Unit of Dose UDI-DI: 04046955203116
- Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490568
- Primary UDI-DI: 04046955275663
- Unit of Dose UDI-DI: 04046955275656
- Expiration Date: Earliest Exp of Comp or 36mths.
Distribution
Distribution scope not specified by the agency.
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