Device product
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
Z-1016-2025
Product summary
- Event
- Event 96068
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 280 units
- Official record key
device-enforcement:Z-1016-2025
Official wording
Reason: Potential for hole in package compromising sterility of the medical kit.
Code information: Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032
Distribution pattern: US Nationwide distribution in the states of MD, PA, TN and TX.
Derived failure modes
-
Unknown
Potential for hole in package compromising sterility of the medical kit.