IV Infusion Pump Set Recalled for Medication Backflow Risk
B. Braun's Infusomat 60 IV infusion pump set is being recalled due to a backcheck valve that may malfunction, allowing medication to flow backward between IV containers and preventing proper priming of the line.
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 for a medical device with potential to cause serious patient harm through medication backflow, treatment interruption, and adverse drug reactions. However, the source text does not report any confirmed illnesses or injuries, placing this in the 'risk-of-harm' category where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat 60 DROP METRISET PUMP SET, Model 490101, an intravenous (IV) infusion pump set used with electrically-powered infusion pumps for intravenous medication administration. Approximately 33,065 units have been distributed throughout the United States and Canada, including all lot numbers distributed after August 1, 2023.
The backcheck valve in the pump set can malfunction, causing medication from secondary (piggyback) IV containers to flow backward into primary IV containers and preventing proper priming of the infusion line. These malfunctions may result in adverse drug reactions, product malfunction, or loss of medication or blood during administration. Patients and healthcare facilities using this pump set should contact B. Braun Medical, Inc. or their healthcare provider regarding this recall.
The recalled product
- Product
- Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 33,065
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 04046964186103
- 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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