Summary
The FDA issued a Class II for Trumpet, Needle Guide, Cat# TMS-200 by Technicality Inc.. Reason: The Ring on the Trump Needle Guide can detach when excessive pressure is applied..
Details
Source
Device Recall
External ID
Z-1460-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
Trumpet, Needle Guide, Cat# TMS-200
Lot/Code Info: Lot Numbers: 22190 & 22497
Quantity Affected: 20000 units
Reason for Recall
The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
Distribution
US Nationwide distribution in the state of Illinois.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-31
Company
Addison, 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 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Technicality Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Technicality Inc. have FDA actions?
This is the only FDA action we have on record for Technicality Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1460-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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