BEUDAMED
    FDA Recall Terminated

    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.

    Recall: Z-2570-2014 · Initiated July 3, 2014

    Recall

    Recall Number
    Z-2570-2014
    Event Number
    68754
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 3, 2014
    Posted
    September 5, 2014
    Terminated
    May 28, 2015
    Address
    75 Vista Pl, Trumbull, CT, 06611-3934

    Description

    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.

    Reason

    Unsealed pouches.

    Action

    Customer notification letter was sent on July 1, 2014 via UPS with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers may have on hand. For questions contact James Keller, Vice President, Regulatory Affairs/Quality Assurance at 203-601-5200.

    Distribution

    Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.

    Quantity

    1,400 units