Class II — Trinity Sterile, Inc.
| Recalling firm | TRINITY STERILE, INC. |
|---|---|
| Registered facility | TRINITY STERILE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for hole in package compromising sterility of the medical kit. |
| 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 |
| Quantity | 1,980 units |
| Distribution | US Nationwide distribution in the states of MD, PA, TN and TX. |
| Initiated | 2024-12-13 |
| Classified | 2025-01-22 |
| Recall number | Z-1013-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Trinity Sterile, Inc. (Z-1013-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96068/
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