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.
FDA Recall Z-1884-2020 · Posted 2020-03-24
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Recalling FirmNorthgate Technologies, Inc.
Recall StatusTerminated
Product CodeFFK
Date Initiated2020-03-10
Date Terminated2021-02-02
Product Quantity198 boxes. 3 units per box.
Reason for Recall
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Firm Action
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".
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution. No governmental.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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