Reported Oct 23, 2013 · Terminated
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for…
Harvest Technologies Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Harvest Technologies Corporation · 40 Grissom Rd Ste 100 · Plymouth, MA · 02360-7205
Is this the product you have?
- Harvest Graft Delivery System
- Model NumberGDP-10
- Product UsageThe 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
- Lot codes and dates
GDP-10-0046GDP-10-0047GDP-10-0048GDP-10-0050GDP-10-0051GDP-10-0052GDP-10-0053GDP-10-0054GDP-10-0055GDP-10i-0010
- Amount recalled
- 730 cases (3 kits per case)
Where it was sold
Why it was recalled
Potential for leur connector to leak or have cracks.
This product could cause temporary or reversible health problems — stop using it.
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