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U.S. Department of Health and Human Services

Class 2 Device Recall Graft Delivery System

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 Class 2 Recall
Graft Delivery System
see related information
Date Posted October 17, 2013
Recall Status1 Terminated on February 10, 2014
Recall Number Z-0022-2014
Recall Event ID 66268
Premarket Notification
510(K) Number
K043261 
Product Classification Syringe, Piston - Product Code FMF
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.
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
Recalling Firm/
Manufacturer
Harvest Technologies Corporation
40 Grissom Rd Ste 100
Plymouth, Massachusetts 02360-7205
For Additional Information Contact Michelle Sullivan
508-732-7500
Manufacturer Reason
for Recall
Potential for leur connector to leak or have cracks.
FDA Determined
Cause 2
DESIGN: Device Design
Action Harvest Technologies sent a notification letter dated September 10, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form to confirm the number of kits received, used, and intending to return. They are asked to return the kits with the form. For questions contact Michelle Sullivan at 508-732-7500.
Quantity in Commerce 730 cases (3 kits per case)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = HARVEST TECHNOLOGIES, CORP.
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