Class II

Medical Device Recall: 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

Trinity Sterile, Inc. · December 13, 2024

Reason for Recall

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

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

1,980 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1012-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.