Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A

Reason: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection

Code information: Lot Code: UDI-DI 00677964064623; Lot Numbers 403142, 403490, 406396, 415623, 420136, 431090, 434467, 439578, 440970, 449929, 453997, 456734, 457984, 460959, 465381, 476333, 480953, 485936, 502488, 505441, 515820, 518697, 530332, 542927, 553320, 554244, 555701, 579924, 585282, 589722, 596830, 607311, 608007, 614507, 618935

Distribution pattern: Worldwide distribution - United States Nationwide and the countries of Canada, Belgium, Czech Republic, Denmark, Germany, Spain, Italy, Slovenia, Slovakia, Australia, Israel, Jordan, Kuwait, Namibia, Saudi Arabia, South Africa, Cote d Ivoire, Afghanistan, Albania, Belarus, Botswana, Kazakhstan, Malaysia, Qatar, Ukraine, United Arab Emirates, Nicaragua, and Nigeria.