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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site)."
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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