Recall Z-0128-2022 ยท HDC Tenaculum, Uterine
Stradis Medical, LLC dba Stradis Healthcare
IUD Insertion Kit
| Date | Sep 10, 2021 |
| Status | Open, Classified |
| Reason | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Root cause | Device Design |
| Action | The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of |
| Quantity | 14959 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073182 | GYN DISPOSABLES TENACULUM 356T Gyn-Disposables, Inc., Nov 28, 2007 |