Recall Z-0022-2014 ยท FMF Syringe, Piston
Harvest Technologies Corporation
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft mat
| Date | Oct 17, 2013 (initiated Sep 11, 2013) |
| Status | Terminated |
| Reason | Potential for leur connector to leak or have cracks. |
| Root cause | Device Design |
| Action | Harvest Technologies sent a notification letter dated September 10, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form to confirm the number of kits received, used, and intending to return. They are asked to return the kits with the form. For questions contact Michelle Sullivan at 508-732-7500. |
| Quantity | 730 cases (3 kits per case) |
| Distribution | Worldwide Distribution - USA Nationwide: TX, NJ, MI, AZ, GA, LA, ME, MD, AR, MO, VA, MN, GA, MA, NY, PA, CO, CA and in the countries of Australia, Brazil, China, Singapore, Vietnam, Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043261 | HARVEST GRAFT DELIVERY SYRINGE Harvest Technologies, Corp., Mar 11, 2005 |