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Terminated

AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

FDA Recall Z-1235-2022 · Posted None

Recalling FirmNorthgate Technologies, Inc.
Recall StatusTerminated
Product CodeFFK
Date Initiated2022-04-13
Date Terminated2022-11-08
Product Quantity55 probes

Reason for Recall

Product labeled incorrectly.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of MA.

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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