Dressing Change Kit Recalled Due to Package Integrity Concern
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—potential package compromise affecting sterility of a medical device—represents a risk-of-harm scenario. Per the rubric, theoretical hazards without reported illness are scored at most 3 (High).
Plain-English summary
Trinity Sterile, Inc. is recalling Wolf-Pak Premium Dressing Change Kits (Model DC5090LF, Lot #600088) due to potential holes in the product packaging that could compromise the sterility of the kit.
The recall affects 5,940 units (198 cases of 30 units each) distributed nationwide in Maryland, Pennsylvania, Tennessee, and Texas.
Consumers who have purchased affected kits should stop using them and contact Trinity Sterile for instructions regarding replacement or refund. Healthcare facilities that have received affected units should quarantine them pending resolution with the manufacturer.
No illnesses or injuries have been reported to date. However, package integrity is critical for maintaining sterility, and compromise of the packaging could allow contamination of the medical device during storage or handling.
The recalled product
- Product
- 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
- Manufacturer
- Trinity Sterile, Inc.
- Hazard
- package-integrity
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No DC5090LF
- UDI-DI 10850007185722
- Lot Number 600088
Distribution
Distributed nationwide across the United States.
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