Burette Assembly With Stopcock Recalled Due to Manufacturing Defect and Leakage Risk
B. Braun Medical is recalling 400 units of a 30ML burette assembly due to a manufacturing defect that may cause leakage, potentially delaying therapy and increasing bloodstream infection risk.
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 recall with potential for serious patient harm including bloodstream infection and life-threatening situations. No illnesses, injuries, or deaths have been reported, placing this in the 'High' category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 30ML Burette Assemblies with Stopcock (Article No. 7A3970) used in contrast management systems. The recall affects 400 units distributed worldwide.
The burette assemblies may leak due to a manufacturing defect. This leakage can delay therapy, increase the risk of bloodstream infection in patients, and expose both patients and healthcare workers to hazardous medication. In some cases, there is potential for life-threatening situations requiring additional medical intervention.
The affected devices were distributed in the United States, Canada, and Singapore. The recalled lot numbers are 0061742253 and 0061751732.
Customers and healthcare facilities should immediately discontinue use of the affected burette assemblies and contact B. Braun Medical for instructions on return or replacement. Healthcare providers should review patient records to determine if any patients received therapy using the recalled devices.
The recalled product
- Product
- 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 400
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)
- UDI-DI: N/A Lots 0061742253 0061751732
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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