Recall Z-1012-2025— Trinity Sterile, Inc.
Class II · Ongoing
Class II FDA medical device recall by Trinity Sterile, Inc., initiated 2024-12-13. FDA's recall record names no specific 510(k) clearance for this event. 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: Potential for hole in package compromising sterility of the medical kit..
- Recalling firm
- Trinity Sterile, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-13
- Firm location
- Salisbury, MD, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.