BEUDAMED
    FDA Recall Terminated

    AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067

    Recall: Z-2657-2010 · Initiated August 11, 2010

    Recall

    Recall Number
    Z-2657-2010
    Event Number
    56565
    FEI Number
    1282497
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    August 11, 2010
    Posted
    October 1, 2010
    Terminated
    June 12, 2012
    Address
    LP 15 Hampshire St, Covidien, Mansfield, MA, 02048-1113

    Description

    AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067

    Reason

    Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any

    Action

    Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any questions please contact, Covidien Customer Service at (800) 962-9888, Option 1.

    Distribution

    Nationwide

    Quantity

    1436 units (359 cases)