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.
What this means for you
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.
- Hazard
- device-malfunction
- medication-backflow
- adverse-drug-reaction
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.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27