Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction
B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.
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: This is an FDA Class II recall for a risk-of-harm medical device where no illnesses or injuries have been reported. The potential hazard—backcheck valve malfunction causing medication backflow—poses a theoretical risk to patient safety but lacks confirmed injury reports, justifying a High (3) severity score.
Plain-English summary
B. Braun Medical, Inc. is recalling Infusomat SPACE Pump IV Set 15D, 110 IN. (Model/Catalog Number 480254). The recall includes approximately 109,464 units with identifier UDI-DI 04046955324798. All affected lots were distributed after August 2, 2023, to facilities worldwide, including throughout the United States and Canada.
The backcheck valve in these IV pump sets may malfunction, allowing medication to backflow from secondary (piggyback) IV containers into primary IV containers. The malfunction could also prevent the pump from priming properly, affecting medication delivery.
This defect could result in patient harm, including adverse drug reactions, loss of medication or blood, and failure of the infusion pump to function correctly.
The recalled product
- Product
- Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- backflow
- valve-malfunction
- adverse-drug-reaction
- medication-loss
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 04046955324798
- All Lots Distributed After 02AUG2023.
Distribution
Distributed nationwide across the United States.
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