BEUDAMED
    FDA Recall Terminated

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    Recall: Z-0820-2011 · Initiated April 30, 2010

    Recall

    Recall Number
    Z-0820-2011
    Event Number
    55976
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125337
    Product Code
    FAF
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    April 30, 2010
    Posted
    December 27, 2010
    Terminated
    December 17, 2011
    Address
    1940 Commerce Drive, Mankato, MN, 56003

    Description

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    Reason

    On April 22, 2010, a decision was made by Coloplast to conduct a field correction based on a report that the Saline Filled Testicular Prosthesis is considered mislabeled. This is solely due to a difference in expiration dates between the Terumo Butterfly Needle included in the kit and the testicular implant. The needle has a 3yr expiration date & the Saline Testicular has a 5yr expiration date.

    Action

    The recall will extend to field personnel who have control of all SFTP Systems. The product is ordered by the customer (physician and/or hospital) directly from a field sales representative who ships the device to them or drops it off in person. Coloplast sent all Field Personnel an email on April 30, 2010, with a copy of a letter dated April 30, 2010 and a follow-up letter dated May 1, 2010. The letters described the problem and the product involved in the recall. The letters included a list of Corrections Required. This included the field personnel receiving a stock of sterile Butterfly Needles based on their home consignment inventory to be provided for use with all Saline Testicular Implants; Copies of customer letters to be provided with each replacement needle; Changes in all Saline Testicular orders, and Field personnel to administer the details of the correction and make the direct customer contacts. For questions, contact the Customer Service/Field Inventory Representative at 612-337-7859 or email: [email protected]

    Distribution

    Worldwide distribution: USA including states of AL, AK, AZ, AR, CO, CT, CA, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI,MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT and WA; and countries of Australia, Canada, Hong Kong and Latin America (Chile, Columbia, Ecuador and Venezuela).

    Quantity

    1018