BEUDAMED
    FDA Recall Terminated

    Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    Recall: Z-0769-05 · Initiated March 18, 2005

    Recall

    Recall Number
    Z-0769-05
    Event Number
    31528
    Firm
    Medline Industries, Inc.
    FEI Number
    3000717925
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 18, 2005
    Posted
    April 27, 2005
    Terminated
    October 17, 2005
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    Reason

    The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.

    Action

    Recalled from the direct account hospitals via letter dated 3/18/05 and 3/23/05. The letters informed the accounts of the occlusion via copy of the MMS recall letter, and listed the Medline reorder number and lot numbers of the custom packs shipped to them, along with the MMS part number contained there in. The accounts were requested to examine their stocks for the affected codes and return them to Medline.

    Distribution

    California, Alabama, Minnesota, Florida and Indiana.

    Quantity

    116 kits