Infusomat UNIV 60 IV Infusion Pump Set Recalled for Valve Malfunction Risk
B. Braun is recalling Infusomat UNIV 60 IV infusion pump sets due to a backcheck valve defect that could cause medication backflow between IV containers and prevent priming, potentially resulting in 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: This is an FDA Class II recall of a critical medical device used for intravenous medication administration. Although no injuries or hospitalizations are explicitly reported in the source, the identified hazard—backcheck valve malfunction causing medication backflow and loss—represents a risk-of-harm scenario where patient injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling Infusomat UNIV 60 DROP PUMP SET units (Model/Catalog Number 490104) due to a potential malfunction in the backcheck valve. The valve defect could allow medication to backflow from secondary (piggyback) IV containers into primary IV containers and prevent the pump from priming correctly.
This malfunction could result in loss of medication or blood and may cause adverse drug reactions or other patient injuries related to improper medication administration.
The recalled units were distributed worldwide, including throughout the United States and Canada. All lots of the product distributed after August 1, 2023 are affected. A total of 59,811 units were involved. The affected product can be identified by UDI-DI 04046964186141.
The recalled product
- Product
- Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 59,811
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 04046964186141
- 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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