Medical Device Recall: Z-0022-2014

FDA Recalls dataset · Firm: Harvest Technologies Corporation · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-09-11 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2014.

Recall Res Number
Z-0022-2014
Recalling Firm / Manufacturer
Harvest Technologies Corporation
FEI Number
1000117351
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-09-11
Date Posted
2013-10-17
Date Terminated
2014-02-10
Product Code
FMF
Event Number
66268
Product Quantity
730 cases (3 kits per case)
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.
Action Details 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.
Distribution Pattern 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.
Code Information / Serial Numbers 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

Related Establishments / Registrations

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