Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
FDA Device Recall #Z-1551-2022 — Class II — June 29, 2022
Recall Summary
| Recall Number | Z-1551-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 29, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Trinity Sterile, Inc. |
| Location | Salisbury, MD |
| Product Type | Devices |
| Quantity | 4,169 cases (125,070 eaches) |
Product Description
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Reason for Recall
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Distribution Pattern
US Nationwide distribution in the states of FL, PA.
Lot / Code Information
UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019
Other Recalls from Trinity Sterile, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1015-2025 | Class II | Brand Name: Wolf-Pak Product Name: Premium Dre... | Dec 13, 2024 |
| Z-1012-2025 | Class II | Brand Name: IMed Products Product Name: Dressi... | Dec 13, 2024 |
| Z-1014-2025 | Class II | Brand Name: Wolf-Pak Product Name: Dressing Ch... | Dec 13, 2024 |
| Z-1013-2025 | Class II | Brand Name: Wolf-Pak Product Name: Dressing Ch... | Dec 13, 2024 |
| Z-1016-2025 | Class II | Brand Name: Tacy Medical, Inc. Product Name: D... | Dec 13, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.