ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technolog
FDA device recall Z-1091-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Fox Hollow Technologies
- Reason for recall
- Devices for which sterility may be compromised.
- Action taken
- On 6/18/04, all consignees were notified via phone call, written letter and on-site visit by the firm's sales reps, informing them of the affected product and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 127 units
- Distribution
- The product received nationwide distribution to 59 medical facilities/doctor's offices and 4 units distributed to firm's field agents.
- Date initiated
- 2004-06-17
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-25
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 (K024243) | Fox Hollow Technologies | 2003-06-20 |