Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the
FDA device recall Z-0022-2014 · posted 2013-10-17 · Terminated
Recall details
- Recalling firm
- Harvest Technologies Corporation
- Reason for recall
- Potential for leur connector to leak or have cracks.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 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
- Date initiated
- 2013-09-11
- Date posted
- 2013-10-17
- Date terminated
- 2014-02-10
- Location
- Plymouth, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARVEST GRAFT DELIVERY SYRINGE (K043261) | Harvest Technologies, Corp. | 2005-03-11 |