Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Mod...
FDA Recall #Z-1012-2025 — Class II — December 13, 2024
Product Description
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 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
1,980 units
Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
Code Information
Model No IM46062, UDI-DI 10853155008769, Lot Number 600022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated