BEUDAMED
    FDA Recall Open, Classified

    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 Intub. Endoscope, REF: 39501F; Wire basket for c-mac videolaryngoscope, REF: 39501LC2; Tray, URS, 644 x 150 x 80 mm, REF: 39501X; Wire Tray, URS, REF: 39501XK; Wire tray PECD, REF: 39501XP; Tray, paranasal sinus shaver system, REF: 39550A

    Recall: Z-1991-2023 · Initiated April 6, 2023

    Recall

    Recall Number
    Z-1991-2023
    Event Number
    92244
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    KCT
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    April 6, 2023
    Posted
    June 21, 2023
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    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 Intub. Endoscope, REF: 39501F; Wire basket for c-mac videolaryngoscope, REF: 39501LC2; Tray, URS, 644 x 150 x 80 mm, REF: 39501X; Wire Tray, URS, REF: 39501XK; Wire tray PECD, REF: 39501XP; Tray, paranasal sinus shaver system, REF: 39550A

    Reason

    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.

    Action

    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 [email protected] Customers correction-related questions can contact [email protected] or 888-943-5128. Customers with device-related questions can call 800-421-0837

    Distribution

    Worldwide - US Nationwide distribution including in the states of IN, MS, MN, AZ, FL, IL, CA, AK, NY, VA, TX, PA, LA, ND, AS, MD, NH, SC, AR, GA, NJ, NC, WA, WI, SD, TN, KY, AL, OK, MO, MA, MI, CT, UT, WY, CO, OH, DC, DE, NM, MT, ME, OR, PA, WV, IA, NE, HI, KS, ID, NV, RI, VT, GU and the country of CA.

    Quantity

    4,933