Infusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow
B. Braun's Infusomat UNIV. 15 IV infusion pump set is being recalled due to a potential backcheck valve malfunction that could cause medication to backflow from secondary into primary IV containers, potentially resulting in patient injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall involves potential for serious patient harm—medication backflow and inability to deliver IV medication—but the source reports no actual injuries or hospitalizations, meeting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV (Model 363030), an electrically-powered IV infusion pump set designed for intravenous medication administration. Approximately 37,776 units have been distributed nationwide in the United States and to Canada.
The backcheck valve in these pump sets may malfunction. If the valve fails, medication from secondary (piggyback) IV containers can backflow into primary IV containers. Additionally, the malfunction may prevent proper priming of the pump, making it unable to deliver medication to patients. These failures could result in medication or blood loss and adverse drug reactions.
The affected pump sets were distributed after August 2, 2023, and are identified by UDI-DI 04046964294259. Healthcare facilities and patients using these devices should contact B. Braun Medical, Inc. for instructions on replacement or return of the affected units. Patients with concerns should consult their healthcare provider.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 37,776
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 04046964294259
- All Lots Distributed After 02AUG2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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