IV Infusion Pump Sets Recalled for Backcheck Valve Malfunction
B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.
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 where the source describes potential harm including medication backflow, loss of medication and blood, and adverse drug reaction without documenting any reported illnesses or injuries. This meets the criterion for High severity as a risk-of-harm medical device.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV (Model 490102), an intravenous (IV) infusion pump set used to deliver medications to patients. The recall affects 5,672,116 units distributed worldwide, including throughout the United States and Canada. All lots distributed after August 1, 2023 are included.
The backcheck valve in the pump set may malfunction, causing medication to flow backward from secondary (piggyback) IV containers into primary IV containers. This malfunction can also prevent the pump from being primed, which is necessary to prepare the device for use and ensure proper medication delivery.
These problems can result in adverse drug reactions, loss of medication, loss of blood, or product malfunction. Patients receiving IV medications through affected pump sets may be at risk if the device fails to deliver medication correctly or if medication from one line contaminates another.
Patients and healthcare providers should stop using affected units immediately. Healthcare facilities should review their inventory and identify recalled pump sets using the model number 490102 and UDI-DI 04046964186127. Contact B. Braun Medical for instructions on returning or replacing affected units.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- valve-malfunction
- medication-backflow
- 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 04046964186127
- All Lots Distributed After 01AUG2023.
Distribution
Distributed nationwide across the United States.
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