BEUDAMED
    FDA Recall Open, Classified

    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

    Recall: Z-2320-2021 · Initiated July 16, 2021

    Recall

    Recall Number
    Z-2320-2021
    Event Number
    88353
    Firm
    Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland
    FEI Number
    3007134520
    Product Code
    BTR
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 16, 2021

    Description

    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

    Reason

    The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

    Action

    The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.

    Distribution

    US Nationwide distribution.

    Quantity

    155030 units