FDAFDA · Food and drugs·Recall number Z-2538-2024
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
Published August 14, 2024 · Recall initiated: June 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- 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.
- Lot
- Lot Code: UDI-DI 00677964086878;Lot Numbers 438165, 472172, 559354, 587523
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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