Z-0022-2014 Class II Terminated
FDA device recall Z-0022-2014 was initiated by Harvest Technologies Corporation on September 11, 2013 and is designated Class II. Reason for recall: Potential for leur connector to leak or have cracks. The recall status is terminated (terminated February 10, 2014). Affected quantity: 730 cases (3 kits per case).
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2013
- Initiation Date
- September 11, 2013
- Termination Date
- February 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 730 cases (3 kits per case)
Product Description
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.
Reason for Recall
Potential for leur connector to leak or have cracks.
Distribution Pattern
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.
Code Information
GDP-10-0046, GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP-10i-0010