Agency classClass IIOur severity:High FDA (Devices)·Z-2400-2024·Announced 2024-07-24

Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction

B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.

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 (adverse drug reactions, loss of critical medication) due to backcheck valve malfunction. No illnesses or injuries reported in the source material, placing this within the risk-of-harm category without confirmed reported harm.

Plain-English summary

B. Braun Medical, Inc. is recalling the Infusomat SPACE IV Pump Set with 2 Caresite, Model 490103. The recall includes 643,608 units with UDI-DI 04046964302107, affecting all lots distributed after August 1, 2023. Distribution was worldwide, including throughout the US and Canada.

The backcheck valve in these IV sets can malfunction, resulting in medication flowing backward from secondary (piggyback) IV containers into the primary IV container. The malfunction may also prevent the IV line from being primed correctly.

These failures could cause adverse drug reactions and loss of medication. Patients receiving IV medication through affected units may be at risk.

The recalled product

Product: Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — IV Infusion Equipment
Hazard: valve-malfunction
backflow-medication
adverse-drug-reaction
medication-loss
Affected units: 643,608

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 04046964302107
All Lots Distributed After 01AUG2023

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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