Recall Z-0022-2014— Harvest Technologies Corporation
Class II · Terminated
Class II FDA medical device recall by Harvest Technologies Corporation, initiated 2013-09-11, terminated 2014-02-10. It names one FDA 510(k) clearance: K043261. 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.. Reason: Potential for leur connector to leak or have cracks..
- Recalling firm
- Harvest Technologies Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-11
- Terminated
- 2014-02-10
- Firm location
- Plymouth, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.