Recall Z-2536-2024 ยท FEB Accessories, Cleaning, For Endoscope
Steris Corporation
Hookup Model/Catalog Number: 2-8-540 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.
| Date | Aug 8, 2024 (initiated Jun 13, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Error in labeling |
| Action | Steris issued Urgent Medical Device Correction letter on 7/10 via FedEx mail. Letter states reason for recall, health risk and action to take: User Action Please ensure the following steps are completed: 1.Locate and destroy your IFU(s) relative to the hookup(s) affected by this recall. 2.Complete the Medical Device Recall Response Form included with this letter. 3.Return the completed Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to 440-392-8963. As you are familiar, users have the ability to update hookup and parameter set settings in the Advantage AERs to corresp |
| Quantity | 37 |
| 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, Mala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102996 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR Medivators Reprocessing Systems, Jan 13, 2011 |