Z-0073-2018 Class II Terminated
FDA device recall Z-0073-2018 was initiated by Northgate Technologies, Inc. on May 24, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated June 9, 2020). Affected quantity: 186.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- May 24, 2017
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186
Product 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 for Recall
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.
Distribution Pattern
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Code Information
Model No. 9-195-371DS, Lot/Serial Number LDS12516