IV Pump Sets Recalled for Potential Backcheck Valve Malfunction
B. Braun Infusomat SPACE IV pump sets may experience backcheck valve malfunction, causing medication backflow between containers and preventing proper IV line priming. This could result in adverse drug reactions, incorrect medication doses, or medication loss.
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 with potential for serious patient harm through medication backflow and adverse drug reactions. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported per the rubric criteria for Score 3.
Plain-English summary
B. Braun Medical, Inc. is recalling Infusomat SPACE PUMP IV sets (Model 362432) due to a potential malfunction of the backcheck valve. The backcheck valve is a critical component designed to prevent backflow of medication between intravenous containers.
A malfunctioning backcheck valve can cause secondary (piggyback) IV medications to flow backward into primary IV containers and may prevent the IV line from being properly primed before use. This could result in patients receiving incorrect medication amounts, experiencing adverse drug reactions, or experiencing loss of prescribed medication or blood products.
The recall affects approximately 2,160 units distributed in the United States and Canada. All lots of the Infusomat SPACE PUMP IV SET manufactured after August 2, 2023 are potentially affected, identified by UDI-DI 04046964182679.
Patients and healthcare providers should discontinue use of affected IV sets immediately. Contact B. Braun Medical, Inc. for replacement units. If you have received IV medications using these sets and have concerns, speak with your healthcare provider.
The recalled product
- Product
- Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 2,160
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 04046964182679
- All Lots Distributed After 02AUG2023.
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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