Recall Z-1091-04 ยท ---
Fox Hollow Technologies
ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063
| Date | Jul 20, 2004 (initiated Jun 17, 2004) |
| Status | Terminated |
| Reason | Devices for which sterility may be compromised. |
| Root cause | Other |
| Action | 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. |
| Quantity | 127 units |
| Distribution | The product received nationwide distribution to 59 medical facilities/doctor's offices and 4 units distributed to firm's field agents. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024243 | REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 Fox Hollow Technologies, Jun 20, 2003 |