Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

FDA Device Recall #Z-1550-2022 — Class II — June 29, 2022

Recall Summary

Recall Number Z-1550-2022
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 2,512 cases (75,360 eaches )

Product Description

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

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: 10850007185746 Case 00850007185749 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012

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.