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U.S. Department of Health and Human Services

Class 2 Device Recall SelfCath Pediatric Catheter

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  Class 2 Device Recall SelfCath Pediatric Catheter see related information
Date Initiated by Firm March 22, 2016
Create Date April 20, 2016
Recall Status1 Terminated 3 on October 11, 2016
Recall Number Z-1525-2016
Recall Event ID 73604
Product Classification Catheter, retention type, balloon - Product Code EZL
Product 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.
Code Information 4464131
Recalling Firm/
Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact Coloplast Customer Service
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 31,320
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.