Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL...
FDA Recall #Z-1014-2025 — Class II — December 13, 2024
Product Description
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 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
3,960 units
Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
Code Information
Model No DC3080LF, UDI-DI 10857800006872, Lot Number 600022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated