Infusomat IV Pump Set Recalled for Backcheck Valve Malfunction
The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.
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 of a risk-of-harm medical device where potential patient injuries (adverse drug reactions, medication loss) have not yet been reported. The hazard involves a theoretical malfunction of a critical valve in IV medication delivery, meeting the rubric criteria for High severity.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat 60DROP METRISET PUMP SET, Model/Catalog Number 362034 (UDI-DI 04046964182570), an intravenous infusion pump set used to deliver medications to patients. All lots distributed after August 10, 2023 are affected. The recall applies to units distributed worldwide, including the United States and Canada. Approximately 280 units are involved.
The backcheck valve in this pump set may malfunction. If this occurs, medication from secondary (piggyback) IV containers can flow backward into primary IV containers, and the pump may be unable to prime properly. This malfunction can result in loss of medication or blood, adverse drug reactions due to improper medication administration, or inability to deliver medication as intended.
Healthcare facilities using this device should stop using affected units immediately. Contact B. Braun Medical, Inc. for further instructions regarding return procedures and replacement options. Patients or caregivers who believe they were affected by this product should consult their healthcare provider.
The recalled product
- Product
- Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 280
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 04046964182570
- All Lots Distributed After 10AUG2023.
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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