FDA-Device2015-11-11Class III
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
C.R. Bard, Inc.
Hazard
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Sold states
Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
Affected count
4,170 each
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2016Don't want to check this manually?
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