AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Company
- Northgate Technologies, Inc.
- Recall Initiated
- March 10, 2020
- Posted
- March 24, 2020
- Terminated
- February 2, 2021
- Recall Number
- Z-1884-2020
- Quantity
- 198 boxes. 3 units per box.
- Firm Location
- Elgin, IL
Reason for Recall
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Distribution
US Nationwide distribution. No governmental.
Lot / Code Info
NTI Catalog Number 9-203-0543.
Root Cause
Nonconforming Material/Component
Action Taken
Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form".
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