Foundation Kit

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

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 this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that the consignee has taken all necessary actions as described above.