FDA-Device2025-12-17Class II
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
C.R. Bard Inc
Hazard
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
Affected count
116 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0905-2026Don't want to check this manually?
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