IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow
B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.
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: FDA Class II medical device recall for a serious potential hazard in IV medication administration. The faulty valve could cause medication backflow and impaired delivery with potential for adverse drug reactions. The recall notice describes the risk of harm but does not explicitly document confirmed injury or hospitalization counts.
Plain-English summary
B. Braun Medical, Inc. is recalling Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. infusion pump sets due to a potential malfunction of the backcheck valve.
The backcheck valve may fail, allowing medication to flow backward from secondary (piggyback) IV containers into primary IV containers. This backflow can result in the inability to properly prime the IV line, potentially reducing medication delivery to patients.
The defect may result in adverse drug reactions and loss of medication or blood. This recall affects 6,843,513 units distributed worldwide, including the U.S. and Canada. All lots distributed after August 1, 2023 are included in this recall.
Patients and healthcare providers should contact B. Braun Medical, Inc. for instructions on how to address the defect or obtain a replacement pump set.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- backflow
- valve-malfunction
- medication-loss
- 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 04046964186080
- All Lots Distributed After 01AUG2023.
Distribution
Distributed nationwide across the United States.
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