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Terminated

Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

FDA Recall Z-1883-2020 · Posted 2020-03-24

Recalling FirmNorthgate Technologies, Inc.
Recall StatusTerminated
Product CodeFFK
Date Initiated2020-03-10
Date Terminated2021-02-02
Product Quantity298 boxes. 3 units per box

Reason for Recall

As part of an 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.

K130368AUTOLITH TOUCH; URO TOUCHNorthgate Technologies, Inc. · 2013-11-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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