FDA-Device2021-10-27Class II
Foundation Kit
Stradis Medical, LLC dba Stradis Healthcare
Hazard
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Sold states
Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
Affected count
790 kits
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
Foundation Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0130-2022Don't want to check this manually?
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