Stradis Medical, LLC dba Stradis Healthcare Recall 88656
Description: Foundation Kit
Stradis Medical, LLC dba Stradis Healthcare Recall 88656 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0130-2022 |
| Event ID | 88656 |
| Event Description | Foundation Kit |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 790 kits |
| Recall Reason | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Device Classification | 20211027 |
| Device Code Info | Part Number: A10 |
| Center Classification Date | 20211016 |
| Recall Initiation Date | 20210910 |
| Recalling Firm | Stradis Medical, LLC dba Stradis Healthcare |
| Initial Notification | Letter |
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