Device product
Foundation Kit
Z-0130-2022
Product summary
- Event
- Event 88656
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 790 kits
- Official record key
device-enforcement:Z-0130-2022
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: A10
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
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.