FDA-Device2025-01-29Class II

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

Trinity Sterile, Inc.
Hazard

Potential for hole in package compromising sterility of the medical kit.

Sold states
US Nationwide distribution in the states of MD, PA, TN and TX.
Affected count
280 units
Manufactured in
201 Kiley Dr, Salisbury, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1016-2025

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