The Recall Desk
HighFDA (Devices)·Z-2489-2019·Announced 2019-10-02

B.Braun Infusion Pump Administration Set Recalled for Potential Leaks

B. Braun Medical is recalling 2,580 Infusomat Space Volumetric Infusion Pump Administration Sets due to a risk of leaking or disconnecting at the Y-site joint.

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: The recall involves a medical device with a risk of harm (leaking/disconnecting) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

B. Braun Medical, Inc. is recalling 2,580 units of the Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032. The recall involves Lot Number 0061641410, which was distributed to the state of Texas and Canada.

The recall was initiated because the administration set has the potential to leak and/or disconnect at the bonded joint between the tubing and the Injection Site (Y-Site). This defect could compromise the integrity of the infusion system.

Healthcare facilities and consumers who have this specific product should stop using it immediately. B. Braun Medical is the recalling firm responsible for managing the recall process.

The recalled product

Product
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Infusion Pumps
Hazard
Affected units
2,580

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 (1)

  • Lot Number 0061641410

Distribution

Distributed in 1 state:

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