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.
FDA Recall Z-1525-2016 · Posted None
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Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeEZL
Date Initiated2016-03-22
Date Terminated2016-10-11
Product Quantity31,320
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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