AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Summary
The FDA issued a Class II for AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe by Northgate Technologies, Inc.. Reason: Product labeled incorrectly..
Details
Source
Device Recall
External ID
Z-1235-2022
Action Date
2022-06-15
Status
Terminated
Category
device
Product Description
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Lot/Code Info: NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.
Quantity Affected: 55 probes
Reason for Recall
Product labeled incorrectly.
Distribution
US Nationwide distribution in the state of MA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-13
Company
Elgin, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Northgate Technologies, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Northgate Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Northgate Technologies, Inc. have FDA actions?
Northgate Technologies, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1235-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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