BEUDAMED
    FDA Recall Terminated

    Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.

    Recall: Z-1525-2016 · Initiated March 22, 2016

    Recall

    Recall Number
    Z-1525-2016
    Event Number
    73604
    Firm
    Coloplast Manufacturing US, LLC
    FEI Number
    2125050
    Product Code
    EZL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 22, 2016
    Terminated
    October 11, 2016
    Address
    1601 W River Rd, Minneapolis, MN, 55411-3431

    Description

    Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.

    Reason

    Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters because a small portion of the lot was identified to have missing eyelets. This recall is based upon a complaint Coloplast received regarding a catheter malfunction.

    Action

    Coloplast sent an "Urgent Medical Device Recall" letter dated March 22, 2016 to customers. The letter described the problem and the product involved in the recall. Advised consignees to immediately examine, quarantine and return the affected product. If the product has been further distributed, consignees should identify their customers and notify them of the recall. It also requested consignees to complete and return the Acknowledgement Form. For questions contact Coloplast Customer Service directly at 800-533-0464.

    Distribution

    US Nationwide Distribution in the states of: AL, AR, C, FL, IL KY, LA, MD, MA, MI, MN, MO, NJ,NY, NC, OK,OR, PA, TN, TX, VA and WA.

    Quantity

    31,320