The Recall Desk
HighFDA (Devices)·Z-0022-2014·Announced 2013-10-23

Harvest Graft Delivery System Recalled for Potential Luer Connector Leaks

Harvest Technologies is recalling 730 cases of the Harvest Graft Delivery System because the Luer connector may leak or crack.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for leakage or cracking, which poses a risk of harm to patients during surgical procedures, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Harvest Technologies Corporation is recalling 730 cases (3 kits per case) of the Harvest Graft Delivery System, Model Number GDP-10. The recall is due to a potential for the Luer connector to leak or have cracks.

The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. It is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. The system is also designed to facilitate pre-mixing of bone graft materials with aspirates, I.V. fluids, blood, plasma, platelet rich plasma, bone marrow, or other specific blood components as deemed necessary by clinical use requirements.

The affected units were distributed worldwide, including nationwide in the United States (TX, NJ, MI, AZ, GA, LA, ME, MD, AR, MO, VA, MN, MA, NY, PA, CO, CA) and in the countries of Australia, Brazil, China, Singapore, Vietnam, and the Dominican Republic. Specific lot codes include GDP-10-0046 through GDP-10-0055 and GDP-10i-0010. Users should stop using the affected devices and contact Harvest Technologies Corporation for further instructions.

The recalled product

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 b
Manufacturer
Harvest Technologies Corporation
Category
Medical Device — Surgical Instrument
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Related recalls

Same hazard · leakage

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