Karl Storz Endoscopy Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2; Wire Tray for ENDOCAMELEON, REF: 39501BEC; Tray, with lid, 670x80x52mm, REF: 39501C; Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC; Wire Tray Retromolar Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.

Recommended Action

Per FDA guidance

On 4/6/23, correction notices were distributed to customers who were informed the following: Affected metal trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132C for 4 minutes with a 20-minute dry time). When used in conjunction with an FDA-cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. The system has been validated with devices with working channels greater-than-or-equal-to 0.2 mm and a maximum length of 240 mm. 1) Ensure that all relevant personnel in your organization review this letter, including the new Instructions for Use for the metal trays: following: https://spwebspace.karlstorz.com/sites/MetalTrays/SitePages/Home.aspx 2) If you have previously sold or transferred any of the affected metal trays to a third party, please forward this notice to all such third parties. 3) Complete and return the Acknowledgment Form to karlstorz5983@sedgwick.com Customers correction-related questions can contact karlstorz5983@sedgwick.com or 888-943-5128. Customers with device-related questions can call 800-421-0837