FDA Recall
Terminated
Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061
Recall: Z-0081-04
·
Initiated October 9, 2003
Recall
- Recall Number
- Z-0081-04
- Event Number
- 27489
- Firm
- Richard Wolf Medical Instrument Corp
- FEI Number
- 1418479
- Product Code
- FFK--
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 9, 2003
- Posted
- July 20, 2004
- Terminated
- February 10, 2004
- Address
- 353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110
Description
Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061
Reason
The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
Action
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.
Distribution
Nebraska, Oregon, Minnesota and Illinois.
Quantity
10 probes