Harvest Technologies Corporation recalls Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for

Recalled October 23, 2013 · FDA recall Z-0022-2014 · Harvest Technologies

Hazard

Potential for leur connector to leak or have cracks. · FDA Class II

Units

730 cases (3 kits per case)

Sold at

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.

Description

Potential for leur connector to leak or have cracks.

Product

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 materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Manufacturer(s)

Harvest Technologies Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →