Stradis Medical, LLC dba Stradis Healthcare recalls Foundation Kit

Recalled October 27, 2021 · FDA recall Z-0130-2022 · Stradis Medical, LLC

Hazard

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. · FDA Class II

Units

790 kits

Sold at

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.

Description

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Product

Foundation Kit

Manufacturer(s)

Stradis Medical, LLC dba Stradis Healthcare

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →