The Recall Desk
HighFDA (Devices)·Z-0578-2026·Announced 2025-12-03

IV set 490487 recalled over piggyback backflow and occlusion risk

B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

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: Scored 3 under the risk-of-harm criterion: medication backflow between IV containers can alter what a patient receives, and no injuries are reported.

Plain-English summary

IV Administration Sets used in gravity IV administration and with B. Braun's Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump are being recalled, including catalog number 490487.

The recall follows the potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers, and the inability to prime the set due to occlusion.

The recall covers 23,160 units carrying primary UDI-DI 04046955086856. Distribution was worldwide, including the United States and internationally to Canada, Germany, Guatemala and Singapore. The FDA has classified the action as Class II.

Backflow can move a secondary medication into the primary bag, and a set that cannot be primed cannot be used. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow B. Braun's instructions.

The recalled product

Product
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Manufacturer
Foundation Medicine, Inc.
Category
Medical Device — IV administration set
Hazard
  • backflow
  • occlusion
  • priming-failure
  • infusion

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 (19)

  • F1LCDx - TECH-0009 version 6.0
  • Test Numbers: ORD-XXX6703-01 (JP)
  • ORD-XXXX411-01 (US)
  • ORD-XXXX128-01 (US)
  • ORD-XXXX061-01 (US)
  • ORD-XXXX270-01 (US)
  • ORD-XXXXX94-01 (US)
  • ORD-XXXX058-01 (US)
  • ORD-XXXX099-01 (US)
  • ORD-XXXX089-01 (US)
  • ORD-XXXX252-01 (US)
  • ORD-XXXX640-01 (US)
  • ORD-XXX5300-01 (US)
  • ORD-XXXX453-01 (US)
  • ORD-XXXX101-01 (US)
  • ORD-XXXX070-01 (US)
  • ORD-XXXX231-01 (US)
  • ORD-XXXX496-01 (US)
  • ORD-XXXX202-01 (US)

Distribution

Distributed nationwide across the United States.

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