Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Rich
FDA device recall Z-0081-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Richard Wolf Medical Instrument Corp
- Reason for recall
- The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
- Action taken
- Recalled from the hospitals by sales representative telephone calls on 10/9/03 and follow-up visits to retriev the recalled lot and replace the units with a new lot of sonotrodes.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 10 probes
- Distribution
- Nebraska, Oregon, Minnesota and Illinois.
- Date initiated
- 2003-10-09
- Date posted
- 2004-07-20
- Date terminated
- 2004-02-10
- Location
- Vernon Hills, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) (K011065) | Richard Wolf Medical Instruments Corp. | 2001-05-09 |