Agency classClass IIOur severity:High FDA (Devices)·Z-2396-2024·Announced 2024-07-24

Infusomat SPACE IV infusion sets recalled for backcheck valve malfunction

Infusomat SPACE IV infusion sets are recalled due to a backcheck valve defect that may cause medication to flow backward into primary IV bags, potentially resulting in medication loss or adverse drug reactions.

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 an FDA Class II recall of a medical device used in critical medication administration. The potential for valve malfunction resulting in medication backflow, loss of medication, and adverse drug reactions represents significant patient safety risk, though no specific incidents have been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling Infusomat SPACE PUMP IV SET 15D, 90 IN. (Model 480263) due to a potential malfunction of the backcheck valve. The backcheck valve is designed to prevent medication from flowing backwards through the IV line.

When the backcheck valve malfunctions, medication from secondary (piggyback) IV containers can flow backward into primary IV containers. This can cause the infusion pump to fail to prime and result in loss of medication or an adverse drug reaction. The defect affects approximately 13,464 units that were distributed worldwide, including throughout the United States and Canada, from September 25, 2023 onward.

Healthcare facilities using this product should discontinue use and contact B. Braun Medical, Inc. for replacement. Healthcare providers who have used this product should monitor for any signs of medication loss or adverse patient reactions.

The recalled product

Product: Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — IV Infusion Set
Hazard: valve-malfunction
medication-backflow
adverse-drug-reaction
Affected units: 13,464

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 04046955693931
All Lots Distributed After 25SEP2023.

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 →

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