Recall Z-1525-2016— Coloplast Manufacturing US, LLC

Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2016-03-22, terminated 2016-10-11. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

Coloplast Manufacturing US, LLC

Classification

Class II

Status

Terminated

Initiated

2016-03-22

Terminated

2016-10-11

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.