Events

Recall of Device Recall SelfCath Pediatric Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Manufacturing US, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73604
  • Event Risk Class
    Class 2
  • Event Number
    Z-1525-2016
  • Event Initiated Date
    2016-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144560
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, retention type, balloon - Product Code EZL
  • 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.

Device

Device Recall SelfCath Pediatric Catheter
  • Model / Serial
    4464131
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Manufacturer Address
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    USFDA