BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
This recall is currently active, issued November 3, 2023. It was issued by B Braun Medical Inc.
- Company
- B Braun Medical Inc
- Recall Initiated
- September 26, 2023
- Posted
- November 3, 2023
- Recall Number
- Z-0136-2024
- Quantity
- 175,000 units
- Firm Location
- Allentown, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Lot / Code Info
UDI-DI: N/A Lot 0061744741, 0061749486
Root Cause
Process control
Action Taken
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.