Infusion Pump Set Recalled Due to Valve Malfunction Risk
B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.
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 recall of a critical IV infusion pump component. No reported cases of injury have been documented, but the malfunction could result in serious patient harm including adverse drug reactions and medication loss, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 60 DROP PUMP SET (Model/Catalog Number 363423), an electrically-powered infusion pump set used for intravenous (IV) medication administration. The recall involves 22,560 units distributed worldwide, including the United States and Canada.
The pump sets are being recalled due to a potential malfunction in the backcheck valve. This malfunction could allow medication to flow backward from secondary (piggyback) IV containers into primary IV containers, and could prevent proper priming of the IV line, resulting in inability to deliver medication to the patient.
These malfunctions could result in patient injuries, including adverse drug reactions and loss of medication or blood. The affected units carry the Universal Product Identifier (UDI-DI) 04046964294655 and include all lots distributed on or after August 4, 2023.
The recalled product
- Product
- Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 22,560
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 04046964294655
- All Lots Distributed After 04AUG2023.
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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