Infusion Pump Sets Recalled for Potential Backflow of Medication
B. Braun is recalling Infusomat UNIV. 15 IV pump sets due to a backcheck valve malfunction that could divert medication between containers and prevent proper priming.
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: FDA Class II recall describing potential for backcheck valve malfunction that could result in adverse drug reactions and loss of medication or blood. However, the source text does not explicitly report confirmed injuries or hospitalizations, making this a risk-of-harm product without documented incident reports.
Plain-English summary
B. Braun Medical, Inc. is recalling Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE infusion pump sets (Model 362033). A total of 47,370 units have been distributed in the United States and Canada.
The backcheck valve in these pump sets may malfunction, potentially allowing medication from secondary IV containers to flow backward into primary IV containers. The malfunction could also prevent the pump set from priming properly, which is necessary for delivering medication. These issues could result in adverse drug reactions, loss of medication, or blood loss.
Healthcare facilities using these pump sets should contact B. Braun Medical, Inc. immediately to learn how to obtain replacement units or receive instructions for safe discontinuation. Patients receiving IV therapy should consult their healthcare provider if they have concerns about their treatment.
This recall includes all pump sets with UDI-DI 04046964837821 distributed after August 1, 2023.
The recalled product
- Product
- Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 362033
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- backflow
- medication-loss
- adverse-drug-reaction
- device-malfunction
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 04046964837821
- All Lots Distributed After 01AUG2023.
Distribution
Distributed nationwide across the United States.
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