FDA Device recall Z-0022-2014
Harvest Graft Delivery System
- FDA Device
- Class II
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class II recall of Harvest Graft Delivery System by Harvest Technologies, citing potential for leur connector to leak or have cracks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0022-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-11 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Harvest Technologies |
| Distribution | US |
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.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2014%22
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