Recall Z-0073-2018 ยท FFK Lithotriptor, Electro-Hydraulic
Northgate Technologies, Inc.
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.
| Date | May 24, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017. Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424. |
| Quantity | 186 |
| Distribution | US Distribution to the following states : MA, NE and TN and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc., Jan 6, 1992 |