FDA-Device2020-05-27Class II
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.
Medline Industries Inc
Hazard
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Sold states
US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.
Affected count
330
Manufactured in
Three Lakes Drive, N/A, Northfield, IL, United States
Products
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2042-2020Don't want to check this manually?
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