FDA Device recall Z-1525-2016
Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306 by Coloplast Manufacturing Us, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1525-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-22 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Coloplast Manufacturing Us |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 4464131 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1525-2016%22
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