30 ML 2port Burette Assembly recall
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
Why was 30 ML 2port Burette Assembly recalled?
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: N/A Lots 0061766049
- Product
- 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 350 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)