Infusion Pump Component Valve Malfunction May Cause Medication Backflow
B. Braun's Infusomat infusion pump component can malfunction, causing medication to flow backward from secondary IV lines into primary lines, potentially resulting in improper medication delivery and patient harm.
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 recall for a medical device with potential for patient harm through medication delivery malfunction and adverse drug reaction. The source does not report confirmed illnesses or injuries, placing this in the risk-of-harm category where injury has not yet been reported.
Plain-English summary
The Infusomat 60DROP METRISET PUMP (Model 363422), manufactured by B. Braun Medical, Inc., is an infusion pump component used with electrically-powered infusion pumps to deliver medication intravenously.
The backcheck valve in this component may malfunction, potentially allowing medication from secondary (piggyback) IV containers to flow backward into primary IV containers. The malfunction may also prevent the pump from priming properly, resulting in loss of medication.
The recall applies to 7,360 units distributed in the United States and Canada, specifically all lots distributed after August 1, 2023 (UDI-DI: 04046964294631). Healthcare facilities using affected units should contact B. Braun Medical, Inc. for guidance on replacement or remediation.
The recalled product
- Product
- Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — IV Infusion
- Affected units
- 7,360
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 04046964294631
- 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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