ConvaTec, Inc recalls Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product U…

Recall date

January 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1037-2019

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, K…

Why it was recalled

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).