Infusion pump IV administration set recalled for backcheck valve malfunction risk
B. Braun is recalling Infusomat UNIV. 15 DROP PUMP SET infusion sets due to potential backcheck valve malfunction that may cause medication to flow backward into primary IV containers and prevent proper priming, risking adverse drug reactions.
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: FDA Class II medical device with a structural/functional defect (backcheck valve malfunction) in a critical medication delivery system that can result in medication backflow, medication loss, and delivery failure with potential for adverse drug reactions. No specific patient injury or hospitalization reports are stated in the recall notice.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET (Model 363421), a sterile infusion set designed for use with electrically-powered infusion pumps in intravenous medication administration. The backcheck valve in these infusion sets can malfunction, potentially allowing medication to flow backward from secondary (piggyback) IV containers into primary IV containers, and may prevent the infusion set from priming properly.
This recall affects infusion sets distributed worldwide, including throughout the United States and Canada. All lots distributed after August 1, 2023, are included in the recall, affecting approximately 1,325,700 units (UDI-DI 04046964294617). When the backcheck valve malfunctions, medication may flow backward between containers or fail to deliver properly, potentially causing loss of medication and adverse drug reactions.
Healthcare facilities using these infusion sets should contact B. Braun Medical, Inc. or their supplier immediately for guidance on replacing or returning affected product. Patients should not discontinue their IV medications but should notify their healthcare provider if they experience any signs of medication delivery problems or unexpected symptoms during treatment.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 1,325,700
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 04046964294617
- All Lots Distributed After 01AUG2023.
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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