Trinity Sterile, Inc.: Device Recall
Recall #Z-1015-2025 · 12/13/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1015-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Trinity Sterile, Inc.
- Status
- Ongoing
- Date Initiated
- 12/13/2024
- Location
- Salisbury, MD, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,940 units
Reason for Recall
Potential for hole in package compromising sterility of the medical kit.
Product Description
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Distribution Pattern
US Nationwide distribution in the states of MD, PA, TN and TX.
Other Recalls by Trinity Sterile, Inc.
- Class II: Risk 12/13/2024
- Class II: Risk 12/13/2024
- Class II: Risk 12/13/2024
- Class II: Risk 12/13/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.