Medline Industries Inc recalls SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flex…

Recall date

May 28, 2019

Source

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

Recall number

Z-2043-2020

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

Why it was recalled

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

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

What was recalled

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.