IV Pump Infusion Set Backcheck Valve May Malfunction and Cause Medication Backflow
B. Braun is recalling the Infusomat UNIV.15DROP PUMP SET (Model 362032) because the backcheck valve may malfunction, allowing medication to flow backward from secondary to primary IV containers, risking medication loss and adverse drug reactions.
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: Class II FDA medical device recall involving a high-risk product (IV infusion equipment) with potential for serious adverse events (medication backflow, inability to prime, adverse drug reactions). No hospitalization reports are documented in the recall notice, placing this at Score 3 (High) rather than Score 4.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL (Model/Catalog Number 362032), an infusion pump set used to deliver medications intravenously (IV) to patients.
The backcheck valve in the pump set may malfunction. When this occurs, medication from secondary (piggyback) IV containers can flow backward into primary IV containers. The pump may also fail to prime correctly, preventing proper medication delivery. These malfunctions can result in medication loss and adverse drug reactions.
This recall affects all units distributed after August 1, 2023. The recalled pump sets have been distributed worldwide, including throughout the US and Canada.
The recalled product
- Product
- Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362032
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 1
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 04046964182556
- 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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