FDA recall Z-1015-2025

Trinity Sterile, Inc. · Class II · device

Product

Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 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-1015-2025