B. Braun Infusomat IV Pump Set Recalled Due to Backflow Risk
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.
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 FDA medical device recall for IV infusion pump sets with potential for serious harm including medication backflow and adverse drug reactions. The source text describes potential consequences without confirming reported hospitalizations or injuries, making this a risk-of-harm product where injury has not yet been documented.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL (Model 362431), used with electrically-powered infusion pumps for intravenous medication administration. A total of 1,152 units have been distributed worldwide, including throughout the United States and Canada.
The backcheck valve in these pump sets may malfunction, potentially allowing medication to backflow from secondary (piggyback) IV containers into primary IV containers. This malfunction could also prevent proper priming of the pump. These issues could result in loss of medication or blood, adverse drug reactions, or other product malfunctions.
The affected units are identified by UDI-DI 04046964294013 and include all lots distributed after August 2, 2023. Patients and healthcare facilities using this product should verify their product's lot and UDI to determine if they have affected units.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- medication-backflow
- adverse-drug-reaction
- device-malfunction
- medication-loss
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 04046964294013
- All Lots Distributed After 02AUG2023.
Distribution
Distributed nationwide across the United States.
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