Coloplast Manufacturing US, LLC: Medical Device Recall in 2016 - (Recall #: Z-1525-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 22, 2016

Date Posted: April 27, 2016

Recall Number: Z-1525-2016

Event ID: 73604

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.

Status: Terminated

Product Quantity: 31,320

Code Information:

4464131

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.

Voluntary or Mandated:

Voluntary: Firm initiated