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
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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
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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 |
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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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