Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard
B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.
What this means for you
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 a medical device with serious potential for patient harm through medication backflow and loss. However, the source text does not report any actual injuries or hospitalizations, making this a risk-of-harm scenario where adverse outcomes have not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 32,752 units of the Infusomat UNIV. 15 DR PUMP SET (Model 363424), a tubing set used with electrically-powered infusion pumps for intravenous medication administration. The recall affects units distributed worldwide, including the U.S. and Canada, with all lots distributed after August 1, 2023.
The backcheck valve in the tubing set may malfunction, causing medication from secondary (piggyback) IV containers to flow backward into primary IV containers. The valve malfunction could also prevent the tubing set from being properly primed. These failures could result in loss of medication or blood, or adverse drug reactions in patients.
This recall affects healthcare facilities, hospitals, and other healthcare settings using these tubing sets for IV medication administration. Affected devices are identified by UDI-DI 04046964837906. For additional information and instructions on obtaining replacement products, healthcare providers should contact B. Braun Medical, Inc. or the FDA.
The recalled product
- Product
- Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- backflow
- medication-loss
- infusion-malfunction
- adverse-drug-reaction
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 04046964837906
- All Lots Distributed After 01AUG2023.
Distribution
Distributed nationwide across the United States.
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