Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: T...
FDA Recall #Z-1016-2025 — Class II — December 13, 2024
Product Description
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Reason for Recall
Potential for hole in package compromising sterility of the medical kit.
Recalling Firm
Trinity Sterile, Inc. — Salisbury, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
280 units
Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
Code Information
Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated