Infusion pump set backcheck valve malfunction may prevent medication delivery
B. Braun Medical is recalling an infusion pump set due to potential backcheck valve malfunction that could cause medication to flow backward into IV containers and prevent proper medication administration. The recall affects 3,624 units distributed worldwide.
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 a Class II medical device recall for a risk-of-harm product (intravenous medication delivery system) where potential for serious consequences (adverse drug reactions, inability to administer prescribed medications) has been identified. The source describes potential hazards without confirming actual reported injuries, meeting the rubric criteria for High severity.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER (Model/Catalog Number 362050). This medical device is used with electrically-powered infusion pumps to administer medications and fluids intravenously. Approximately 3,624 units have been distributed worldwide, including throughout the United States and Canada, with all affected lots distributed after August 8, 2023.
The backcheck valve in the recalled device may malfunction. When this occurs, medication from secondary (piggyback) intravenous containers can flow backward into primary containers, and the pump may be unable to prime properly. This could result in patients not receiving their prescribed medications, potentially leading to adverse drug reactions and loss of medication or blood being infused.
Patients currently receiving intravenous medications through infusion pumps using this device should contact their healthcare provider. Healthcare providers and facilities should identify affected units using the UDI-DI code 04046964182655, verify lot numbers to confirm if their devices are affected, and discontinue use of recalled units.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device
- Affected units
- 3,624
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 04046964182655
- All Lots Distributed After 08AUG2023.
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.
See all 29 products in this recall →Related recalls
Same manufacturer · B. Braun Medical, Inc.
See all →- ModerateB Braun SAFSITE Injection Site Valve Recall for Leakage Risk
FDA (Devices) · 2026-10-28
- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · valve malfunction
See all →- ModerateNitrous Oxide Cartridges Recalled Due to Premature Valve Opening
FDA (Devices) · 2025-02-12
- HighInfusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow
FDA (Devices) · 2024-07-24
- HighIV Infusion Pump Sets Recalled for Backcheck Valve Malfunction
FDA (Devices) · 2024-07-24
- HighInfusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction
FDA (Devices) · 2024-07-24
- HighInfusomat SPACE IV infusion sets recalled for backcheck valve malfunction
FDA (Devices) · 2024-07-24
Similar recalls
- HighInfusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
FDA (Devices) · 2021-10-06
- SevereB.Braun Infusion Pump Administration Set Recalled for Potential Leaks
FDA (Devices) · 2019-10-02
- HighInfusion pump sets recalled over medication backflow and occlusion
FDA (Devices) · 2025-12-03
- SevereInfusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication
FDA (Devices) · 2023-11-01
- SevereInfusomat Space Infusion Pump Recall Due to Sensor Malfunction
FDA (Devices) · 2024-09-18
- HighOutlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk
FDA (Devices) · 2021-10-06