30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
Recall
- Recall Number
- Z-0135-2024
- Event Number
- 93074
- Firm
- B. Braun Medical, Inc.
- FEI Number
- 2523676
- Product Code
- DXT
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 26, 2023
- Posted
- November 3, 2023
- Address
- 901 Marcon Blvd, Allentown, PA, 18109-9512
Description
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
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.
On September 26, 2023, the firm notified customers via Urgent Product Recall Notification letters. Customers were informed of the potential for leakage at the male Luer lock site. Customers were instructed to report total amount of impacted product on hand to the firm, after which B Braun Customer Support will contact the customer with instructions on how to return the product for credit or replacement depending on the customer's need. Questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
400 units