B. Braun Medical, Inc. recalls AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, f
Recalled Product
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Hazard / Issue
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.
Issued by
FDA
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