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Medivators Hookup recallZ-2537-2024 · Steris Corporation · initiated Jun 13, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Error in labeling

What the company is doing

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: [email protected] 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.

Recall details

Recall number
Z-2537-2024
Status
Open, Classified
Initiated by the company
Jun 13, 2024
Posted by the FDA
Aug 8, 2024
Recalling firm
Steris Corporation
Quantity
129
Product code
FEB
FDA submissions
K102996
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.

Product description

Hookup Model/Catalog Number: 2-8-540HAN 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.

Code information (models, lots, serial numbers)

Lot Code: UDI-DI 00677964086885; Lot Numbers 415308, 415665, 422921, 456865, 458947, 461749, 463591, 465821, 467121, 467705, 468813, 480858, 484468, 513285, 517588, 533998, 544724, 585095, 617851

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

98 devices cleared under K102996 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94987).

Sources and updates

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