BEUDAMED
    FDA Enforcement Class II Ongoing

    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

    Recall: Z-0184-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0184-2022
    Event ID
    88694
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    September 10, 2021
    Classification Date
    October 29, 2021
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

    Reason

    During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.

    Code Info

    All LOTs with remaining shelf life

    Distribution

    US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT. OUS: Canada

    Quantity

    532