BEUDAMED
    FDA Recall Terminated

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    Recall: Z-1824-2015 · Initiated April 13, 2015

    Recall

    Recall Number
    Z-1824-2015
    Event Number
    71313
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HIB
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    April 13, 2015
    Posted
    June 22, 2015
    Terminated
    February 5, 2016
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures

    Reason

    Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

    Action

    CooperSurgical sent an Urget Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to discontinue use, discard, or return the affected to product to Cooper Surgical. Customers were asked to complete the attached Acknowledgment and Receipt Form for replacement. Customers with questions were instructed to call 203-601-5200.

    Distribution

    Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.

    Quantity

    9400 units