BEUDAMED
    FDA Recall Terminated

    CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02

    Recall: Z-1239-2015 · Initiated February 9, 2015

    Recall

    Recall Number
    Z-1239-2015
    Event Number
    70502
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HHW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 9, 2015
    Posted
    March 3, 2015
    Terminated
    January 15, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02

    Reason

    Incorrect size printed on the Milex Pessary Kit packaging label

    Action

    CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Questions contact CooperSurgical 203.601.5200.

    Distribution

    Nationwide Distribution

    Quantity

    95 units