BEUDAMED
    FDA Recall Terminated

    Colpo-Pneumo Occluder, Part CPO-6

    Recall: Z-0098-2019 · Initiated September 4, 2018

    Recall

    Recall Number
    Z-0098-2019
    Event Number
    80993
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 4, 2018
    Terminated
    May 27, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Colpo-Pneumo Occluder, Part CPO-6

    Reason

    The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

    Action

    Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers do the following: Please be advised that CooperSurgical has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. If any product from the 26 lots is in your possession and has a green label affixed to the outer display box as displayed below, it is not affected by this recall action. A product is acceptable for use if it is visually confirmed that the pouchs seal is intact. As indicated in the Directions for Use (DFU), each package should be handled with care and inspected for damage, including the seal area before use. Inspect the package contents and the sterile seal along the entire periphery of the package. Refer to the table below for examples of acceptable / not acceptable conditions. Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once the form is completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you do not have affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.

    Distribution

    The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.

    Quantity

    32538