The Recall Desk
HighFDA (Devices)·Z-2381-2024·Announced 2024-07-24

Infusion pump set backcheck valve malfunction may prevent medication delivery

B. Braun Medical is recalling an infusion pump set due to potential backcheck valve malfunction that could cause medication to flow backward into IV containers and prevent proper medication administration. The recall affects 3,624 units distributed worldwide.

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: This is a Class II medical device recall for a risk-of-harm product (intravenous medication delivery system) where potential for serious consequences (adverse drug reactions, inability to administer prescribed medications) has been identified. The source describes potential hazards without confirming actual reported injuries, meeting the rubric criteria for High severity.

Plain-English summary

B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER (Model/Catalog Number 362050). This medical device is used with electrically-powered infusion pumps to administer medications and fluids intravenously. Approximately 3,624 units have been distributed worldwide, including throughout the United States and Canada, with all affected lots distributed after August 8, 2023.

The backcheck valve in the recalled device may malfunction. When this occurs, medication from secondary (piggyback) intravenous containers can flow backward into primary containers, and the pump may be unable to prime properly. This could result in patients not receiving their prescribed medications, potentially leading to adverse drug reactions and loss of medication or blood being infused.

Patients currently receiving intravenous medications through infusion pumps using this device should contact their healthcare provider. Healthcare providers and facilities should identify affected units using the UDI-DI code 04046964182655, verify lot numbers to confirm if their devices are affected, and discontinue use of recalled units.

The recalled product

Product
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device
Hazard
  • valve-malfunction
  • medication-backflow
  • adverse-drug-reaction

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 (2)

  • UDI-DI 04046964182655
  • All Lots Distributed After 08AUG2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category