Z-1525-2016Class II

Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306

Name: Z-1525-2016 Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306
Creator: Coloplast Manufacturing US, LLC
Published: 2016-03-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2016-03-22 / Terminated / root cause: manufacturing process

FDA source

Coloplast Manufacturing US, LLC began a recall of Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this... on 2016-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1525-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-22
Posted: 2016-04-20
Terminated: 2016-10-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: EZL Catheter, Retention Type, Balloon
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 4464131

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1525-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1525-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19

Product code EZL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)