FDA recall Z-1016-2025

Trinity Sterile, Inc. · Class II · 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

Reason for recall

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

Distribution

US Nationwide distribution in the states of MD, PA, TN and TX.

Key facts

Status
Ongoing
Initiation date
2024-12-13
Report date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salisbury, MD, United States

Primary source

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