Device 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
Z-1012-2025
Product summary
- Event
- Event 96068
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,980 units
- Official record key
device-enforcement:Z-1012-2025
Official wording
Reason: Potential for hole in package compromising sterility of the medical kit.
Code information: Model No IM46062, UDI-DI 10853155008769, Lot Number 600022
Distribution pattern: US Nationwide distribution in the states of MD, PA, TN and TX.
Derived failure modes
-
Unknown
Potential for hole in package compromising sterility of the medical kit.