The Recall Desk
Severity pendingFDA (Devices)·Z-0664-2026·Announced 2025-12-03

IV Administration Set utilized in gravity IV administration sets and pump administration sets utiliz

Pending LLM rewrite. Source: FDA_DEVICE Z-0664-2026.

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
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, 15 DR/ML,2 CA
Manufacturer
B Braun Medical Inc

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: 490315
  • Primary UDI-DI: 04046964527173
  • Unit of Dose UDI-DI: 04046964525612. 2.Catalog Number: 490331
  • Primary UDI-DI: 04046964541148
  • Unit of Dose UDI-DI: 04046964541131. 3. Catalog Number: 490376
  • Primary UDI-DI: 04046964718182
  • Unit of Dose UDI-DI: 04046964718175.

Distribution

Distribution scope not specified by the agency.