Device product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Z-1013-2025
Product summary
- Event
- Event 96068
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,980 units
- Official record key
device-enforcement:Z-1013-2025
Official wording
Reason: Potential for hole in package compromising sterility of the medical kit.
Code information: Model No DC3077LF, UDI-DI 10857800006841, Lot Number 600018
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.