FDA recall Z-1012-2025

Product

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.

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-1012-2025