FDA-Device2021-10-27Class II
Tenaculum, Plastic
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
2483 kits
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
Tenaculum, Plastic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2022Don't want to check this manually?
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