B. Braun Infusomat 60 IV Pump Sets Recalled for Backcheck Valve Malfunction
B. Braun is recalling Infusomat 60 infusion pump sets (Model 363010) due to potential backcheck valve malfunction. The defect could cause medication to flow backward into primary IV containers and prevent proper medication delivery.
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: FDA Class II medical device recall with potential for significant patient harm through medication delivery failure and backflow. The source identifies risk of adverse drug reactions and loss of medication or blood, classified as a risk-of-harm product without documented reported injuries.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat 60 DROP METRISET PUMP SET (Model 363010) used for intravenous (IV) medication administration. The recall affects 100 units distributed worldwide, including throughout the United States and Canada. All lots distributed after September 5, 2023, are included in this recall.
The backcheck valve in these pump sets may malfunction, causing medication to flow backward from secondary (piggyback) IV containers into primary IV containers. This malfunction could also prevent the pump from priming properly, resulting in the inability to deliver medication or potential loss of blood during IV therapy.
Patients and healthcare providers using affected pump sets should stop using them immediately and contact B. Braun Medical, Inc. for replacement instructions and information. Anyone who has received medication through an affected pump set should consult their healthcare provider.
The recalled product
- Product
- Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 100
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 04046964294174
- All Lots Distributed After 05SEP2023.
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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