BEUDAMED
    FDA Recall Terminated

    Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.

    Recall: Z-0764-05 · Initiated February 21, 2005

    Recall

    Recall Number
    Z-0764-05
    Event Number
    31451
    Firm
    MMS Sales Corp
    FEI Number
    3004752896
    Product Code
    CAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2005
    Posted
    April 27, 2005
    Terminated
    December 20, 2006
    Address
    218 Highline Rd, Pharr, TX, 78577-9726

    Description

    Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.

    Reason

    Partial occlusion in the T-piece resulting in airway obstruction.

    Action

    The firm initiated the recall on February 21, 2004 by letter to all consignees.

    Distribution

    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand

    Quantity

    Total for all products: 7455 cases (161,273 units)