—#209037

Product

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.

FDA product code: FEB — Accessories, Cleaning, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K102996
Affected lot / code info: Lot Code: UDI-DI 00677964086878;Lot Numbers 438165, 472172, 559354, 587523

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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 correspond with your inventory of endoscopes. For your convenience, we have included an excerpt from the Operator Manual (Advantage Plus Pass-Thru, pages 138-140, and Advantage Plus, page 72) of the instructions on how to make these updates (see Attachment A or B, as applicable). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local STERIS Representative or STERIS Technical Support at 800-548-4873 or 800-444-4729.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-06-13
Posted by FDA: 2024-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209037. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.