BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1991-2023
    Event ID
    92244
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    April 6, 2023
    Classification Date
    June 21, 2023
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017, United States

    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.

    Code Info

    REF/UDI-DI: 11580A/ 04048551051801; 11580B/ 04048551051818; 11580C/ 04048551051825; 11580D/ 04048551051832; 39501A1/ 04048551157619; 39501A2/ 04048551157626; 39501B2/ 04048551157657; 39501BEC/ 04048551241400; 39501C/ 04048551157671; 39501CEC/ 04048551254158; 39501F/ 04048551157695; 39501LC2/ 04048551273432; 39501X/ 04048551157756; 39501XK/ 04048551157763; 39501XP/ 04048551157770; 39550A/ 04048551157879. All lots.

    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