Trumpet, Needle Guide, Cat# TMS-200

This recall is currently active, issued April 2, 2024. It was issued by Technicality Inc..

Company

Technicality Inc.

Recall Initiated

January 31, 2024

Posted

April 2, 2024

Recall Number

Z-1460-2024

Quantity

20000 units

Firm Location

Addison, IL

Official Source

View on FDA website ↗

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.

Lot / Code Info

Lot Numbers: 22190 & 22497

Root Cause

Process control

Action Taken

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.