BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 24, 2022

    Recall

    Recall Number
    Z-0245-2023
    Event Number
    91000
    Firm
    Tollos
    FEI Number
    3008406502
    Product Code
    FNG
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    October 24, 2022
    Posted
    November 17, 2022
    Address
    8 Easter Ct, Ste J, Owings Mills, MD, 21117-3294

    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).

    Action

    On October 24, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. The firm is updating their operator's manual and service manual with instructions to inspect the IC straps prior to use, along with photo illustrations of lifting straps demonstrating wear/damage conditions that indicate replacement must be performed. Access complete Operator s & Service Manuals on the web at www.tollos.com/service-bulletins. Tollos can be contacted by e-mail at [email protected].

    Distribution

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

    Quantity

    1273 US; 70 OUS