FDAMarch 22, 2016device

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 wi...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

coloplast manufacturingcoloplast

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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