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
Reported: January 29, 2025 Initiated: December 13, 2024 #Z-1012-2025
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.
Details
- Recalling Firm
- Trinity Sterile, Inc.
- Units Affected
- 1,980 units
- Distribution
- US Nationwide distribution in the states of MD, PA, TN and TX.
- Location
- Salisbury, MD
Frequently Asked Questions
What product 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. Recalled by Trinity Sterile, Inc.. Units affected: 1,980 units.
Why was this product recalled? ▼
Potential for hole in package compromising sterility of the medical kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-1012-2025.
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