Recall Z-1235-2022 ยท FFK Lithotriptor, Electro-Hydraulic
Northgate Technologies, Inc.
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
| Date | Apr 13, 2022 |
| Status | Terminated |
| Reason | Product labeled incorrectly. |
| Root cause | Under Investigation by firm |
| Action | The firm sent out the recall notification to their consignee on 04/13/2022 via email. The firm sent out a letter as well on 04/27/2022 which instructs the consignee to cease distribution, quarantine affected units and return affected product. If the distributor further distributed the product, they are asked to notify their customers. |
| Quantity | 55 probes |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130368 | AUTOLITH TOUCH; URO TOUCH Northgate Technologies, Inc., Nov 15, 2013 |