Z-1525-2016 Class II Terminated
FDA device recall Z-1525-2016 was initiated by Coloplast Manufacturing US, LLC on Mar 22, 2016 and is designated Class II. 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… The recall status is terminated (terminated Oct 11, 2016). Affected quantity: 31,320.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2016
- Initiation Date
- Mar 22, 2016
- Termination Date
- Oct 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,320
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.
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.
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.
Code Information
4464131
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1525-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026