FDA Enforcement
Class II
Terminated
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Recall: Z-0073-2018
·
Reported November 15, 2017
Enforcement
- Recall Number
- Z-0073-2018
- Event ID
- 77367
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Northgate Technologies, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2017
- Initiation Date
- May 24, 2017
- Classification Date
- November 8, 2017
- Termination Date
- June 9, 2020
- Address
- 1591 Scottsdale Ct, N/A, Elgin, IL, 60123-9361, United States
Description
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Reason
The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
Code Info
Model No. 9-195-371DS, Lot/Serial Number LDS12516
Distribution
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Quantity
186