BEUDAMED
    FDA Recall Terminated

    Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.

    Recall: Z-2479-2010 · Initiated August 26, 2010

    Recall

    Recall Number
    Z-2479-2010
    Event Number
    56676
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 26, 2010
    Posted
    September 23, 2010
    Terminated
    August 23, 2011
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military anesthesiologists/ CRNAs in the field of operations. Can be used in a variety of mobile and stationary military applications where general anesthesia is required.

    Reason

    potential failures to Electri-Cord Manufacturing AC power cord

    Action

    Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: [email protected]. 4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed. NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266. If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).

    Distribution

    Worldwide Distribution: USA and countries of Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela

    Quantity

    up to 1973 products (GS & Tiro)