BEUDAMED
    FDA Recall Open, Classified

    Puritan Bennett Cuff Pressure Manager, REF: 180-03

    Recall: Z-2651-2023 · Initiated August 22, 2023

    Recall

    Recall Number
    Z-2651-2023
    Event Number
    92941
    Firm
    Covidien
    FEI Number
    2936999
    Product Code
    BSK
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    August 22, 2023
    Posted
    September 29, 2023
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    Puritan Bennett Cuff Pressure Manager, REF: 180-03

    Reason

    Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.

    Action

    On 8/22/23 Medtronic mailed recall notices to risk managers and directors of respiratory care informing them of the following: 1) Discontinue use, quarantine, and return affected devices to the firm. 2) Complete and return the customer confirmation form via email to it to [email protected]. 3) Forward the notice to all those who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers has been transferred or distributed. If you have any questions regarding this communication, contact customer service at 800-962-9888, Option 2. Quality problems can be reported to Quality Assurance at 800-255-6774 option 4.

    Distribution

    US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands

    Quantity

    408