Z-0022-2014Class II

Harvest Graft Delivery System; Model Number: GDP-10

Name: Z-0022-2014 Harvest Graft Delivery System; Model Number: GDP-10
Creator: Harvest Technologies Corporation
Published: 2013-09-11
License: https://open.fda.gov/license/

Terumo BCT, Ltd / initiated 2013-09-11 / Terminated / root cause: design

FDA source

Harvest Technologies Corporation began a recall of Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous... on 2013-09-11. FDA classified it as Class II and gives the reason as "Potential for leur connector to leak or have cracks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0022-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-11
Posted: 2013-10-17
Terminated: 2014-02-10
Recalling firm: Terumo BCT, Ltd
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.
Product code: FMF Syringe, Piston
Reason for recall: Potential for leur connector to leak or have cracks.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0022-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0022-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code FMF

K043261Class IIHarvest Graft Delivery SyringeHarvest Technologies, Corp. / cleared 2005-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)