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Steris Corporation recalls Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated
Recalled August 14, 2024 · FDA recall Z-2539-2024 · Steris
Hazard
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 · FDA Class II
Units
1082
Sold at
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.
Description
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
Product
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
Manufacturer(s)
Steris Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →