Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interfac...
FDA Recall #Z-2539-2024 — Class II — June 13, 2024
Product Description
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 for Recall
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
Recalling Firm
Steris Corporation — Mentor, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1082
Distribution
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.
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated