Home / Recalls / Medical Devices
B. Braun Medical, Inc. recalls BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
Recalled November 15, 2023 · FDA recall Z-0136-2024 · B. Braun Medical
Hazard
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. · FDA Class II
Units
175,000 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Description
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.
Product
BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
Manufacturer(s)
B. Braun Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →