Trinity Sterile, Inc. recalls Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM460…
- Recall date
- December 13, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1012-2025
- FDA classification
- Class II
- Brand / firm
- Trinity Sterile, Inc.
- Sold / distributed
- US Nationwide distribution in the states of MD, PA, TN and TX.
Why it was recalled
Potential for hole in package compromising sterility of the medical kit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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