SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Ma
FDA device recall Z-1162-2010 · posted 2010-03-18 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- Reason for recall
- ev3 Inc. is conducting a voluntary recall of specific lots of the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage to the packaging.
- Action taken
- Consignees were sent an ev3 "Medical Device Recall" letter dated January 21, 2010. The letter was addressed to Cath Lab Manger/Risk Manager. The letter described the Issue Summary, Affected Product, and Required Action. The letter instructed customers to locate and remove from use the specified Cutter Driver(s). Customers are to complete and return the "Device Recall Field Action Reconciliation Form." An ev3 rep will assist in arranging for the return of all unused product and a replacement will be provided. Questions regarding the recall should be directed to ev3 Customer Service at 1-800-716-6700.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 8,330
- Distribution
- Worldwide Distribution -- USA, with the exception of AK and VT, and countries of AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, FRANCE, GERMANY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANO
- Date initiated
- 2010-01-21
- Date posted
- 2010-03-18
- Date terminated
- 2012-04-26
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K061188) | Foxhollow Technologies, Inc. | 2006-10-23 |