Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Self-Cath¿ Pediatric Catheter Size CH 06 Recalled by Coloplast Manufacturing US, LLC Due to Coloplast Corp. is voluntarily recalling a single lot...

Date: March 22, 2016
Company: Coloplast Manufacturing US, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Coloplast Manufacturing US, LLC directly.

Affected Products

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.

Quantity: 31,320

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Coloplast Manufacturing US, LLC

Coloplast Manufacturing US, LLC has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report