Z-0131-2022 Class II Ongoing
FDA device recall Z-0131-2022 was initiated by Stradis Medical, LLC dba Stradis Healthcare on September 10, 2021 and is designated Class II. Reason for recall: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. The recall status is ongoing. Affected quantity: 280 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 10, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 kits
Product Description
Standard IUD Insertion Kit
Reason for Recall
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
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.
Code Information
Part Number: M20