Infusomat SPACE Pump IV Set Recalled Due to Backcheck Valve Malfunction
B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.
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 device malfunction resulting in adverse drug reactions and medication loss. While the recall describes significant patient safety risks through valve malfunction and unintended medication backflow, no confirmed hospitalizations or injuries are explicitly reported in the source text, consistent with the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat SPACE Pump IV Set (Model 480255) worldwide, including distribution in the United States and Canada. The recalled product is used with electrically-powered infusion pumps for intravenous medication administration.
The recall was issued due to a potential malfunction of the backcheck valve in the IV set. This malfunction could cause backflow of medication from secondary (piggyback) IV containers into primary IV containers and prevent proper priming of the IV line. These failures could lead to adverse drug reactions and loss of medication or blood.
Approximately 1,872 units have been distributed. The affected products are identified by UDI-DI 04046955324804, and all lots distributed after September 6, 2023 are included in the recall.
Healthcare providers and patients should immediately discontinue use and contact B. Braun Medical, Inc. for replacement products. Healthcare facilities should inspect their inventory for the recalled model and lot numbers.
The recalled product
- Product
- Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 1,872
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 04046955324804
- All Lots Distributed After 06SEP2023.
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 · device malfunction
See all →- ModerateMedtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic NDI Passive Spheres Recalled for Reflective Material Variation
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
- SevereVentec VC+Pro Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
- SevereVentec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28
Similar recalls
- SevereInfusomat Space Infusion Pump Recall Due to Sensor Malfunction
FDA (Devices) · 2024-09-18
- HighB. Braun Recalls Infusomat Space Pump IV Sets Due to Missing Filter
FDA (Devices) · 2018-07-04
- HighIV set 490385 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- SevereB.Braun Infusion Pump Administration Set Recalled for Potential Leaks
FDA (Devices) · 2019-10-02
- HighIV set 490208 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490067 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03