AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

Reason: 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.

Code information: UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.