Steris Corporation Recall 94987
Description: 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.
Steris Corporation Recall 94987 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2538-2024 |
| Event ID | 94987 |
| Event Description | 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. |
| Product Type | Devices |
| 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. |
| Quantity | 6 |
| Recall 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 |
| Device Classification | 20240814 |
| Device Code Info | Lot Code: UDI-DI 00677964086878;Lot Numbers 438165, 472172, 559354, 587523 |
| Center Classification Date | 20240808 |
| Recall Initiation Date | 20240613 |
| Recalling Firm | Steris Corporation |
| Initial Notification | Letter |
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