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U.S. Department of Health and Human Services

Class 2 Device Recall Trumpet Needle Guide

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  Class 2 Device Recall Trumpet Needle Guide see related information
Date Initiated by Firm January 31, 2024
Date Posted April 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-1460-2024
Recall Event ID 94135
Product Classification Instrument, manual, surgical, general use - Product Code MDM
Product Trumpet, Needle Guide, Cat# TMS-200
Code Information Lot Numbers: 22190 & 22497
Recalling Firm/
Manufacturer		 Technicality Inc.
661 S Addison Rd
Addison IL 60101-4648
For Additional Information Contact Omer Ahmed
773-344-5289
Manufacturer Reason
for Recall		 The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
FDA Determined
Cause 2		 Process control
Action Technicality Medical Supplies, Inc. issued a Urgent Field Safety Notice to its sole consignee via email on 01/31/2024. The notice explained the problem with the device and requested the consignee quarantine any affected product in inventory and contact their customers.
Quantity in Commerce 20000 units
Distribution US Nationwide distribution in the state of Illinois.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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