BEUDAMED
    FDA Enforcement Class II Ongoing

    Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000

    Recall: Z-0245-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0245-2023
    Event ID
    91000
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tollos
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    October 24, 2022
    Classification Date
    November 17, 2022
    Address
    8 Easter Ct Ste J, N/A, Owings Mills, MD, 21117-3294, United States

    Description

    Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000

    Reason

    Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s).

    Code Info

    UDI-DI 00817956021 (not yet uploaded to GUDID)

    Distribution

    Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.

    Quantity

    1273 US; 70 OUS