Z-1013-2025 Class II Ongoing
FDA device recall Z-1013-2025 was initiated by Trinity Sterile, Inc. on December 13, 2024 and is designated Class II. Reason for recall: Potential for hole in package compromising sterility of the medical kit. The recall status is ongoing. Affected quantity: 1,980 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 13, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,980 units
Product Description
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
Reason for Recall
Potential for hole in package compromising sterility of the medical kit.
Distribution Pattern
US Nationwide distribution in the states of MD, PA, TN and TX.
Code Information
Model No DC3077LF, UDI-DI 10857800006841, Lot Number 600018