IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk
B. Braun is recalling the Infusomat UNIV. 15 DROP PUMP SET due to potential backcheck valve malfunction that could cause medication backflow and loss. The defect may result in adverse drug reactions or improper medication delivery.
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 recall involving potential for medication backflow and loss of medication. Classified as a risk-of-harm product where no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at maximum 3 (High).
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET (Model/Catalog Number 363230) used with electrically-powered infusion pumps for intravenous medication administration. The recall affects approximately 158,904 units distributed nationwide in the United States and Canada, with all lots distributed after August 1, 2023.
The backcheck valve in these pump sets may malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers. This malfunction can also prevent proper priming of the pump set, leading to loss of medication or blood.
These defects could result in patient injury from adverse drug reactions or failure of the infusion system. Healthcare providers and patients using these pump sets should discontinue use and contact B. Braun Medical, Inc. for replacement or return instructions.
Affected units are identified by UDI-DI 04046964294495 and include all lots distributed after August 1, 2023.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 158,904
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 04046964294495
- 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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