Recall Z-1235-2022— Northgate Technologies, Inc.

Name: FDA recall Z-1235-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-13

Class II · Terminated

Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2022-04-13, terminated 2022-11-08. It names one FDA 510(k) clearance: K130368. Product: AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe. Reason: Product labeled incorrectly..

Recalling firm: Northgate Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-04-13
Terminated: 2022-11-08
Firm location: Elgin, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K130368 — AUTOLITH TOUCH; URO TOUCHNorthgate Technologies, Inc.·cleared 2013-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

Reason for recall

Product labeled incorrectly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.