FDA-Device2016-09-21Class II
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
C.R. Bard, Inc.
Hazard
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Sold states
US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
Affected count
274 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2830-2016Don't want to check this manually?
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