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Recall Observatory FDA recall evidence

Device product

Standard IUD Insertion Kit

Z-0131-2022

September 10, 2021

Class II

Product summary

Firm
Stradis Medical, LLC dba Stradis Healthcare
Event
Event 88656
Status
Ongoing
Classification
Class II
Quantity
280 kits
Official record key
device-enforcement:Z-0131-2022

Official wording

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

Code information: Part Number: M20

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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