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Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 M...

FDA Recall #Z-1015-2025 — Class II — December 13, 2024

Recall #Z-1015-2025 Date: December 13, 2024 Classification: Class II Status: Ongoing

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

Reason for Recall

Potential for hole in package compromising sterility of the medical kit.

Recalling Firm

Trinity Sterile, Inc. — Salisbury, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5,940 units

Distribution

US Nationwide distribution in the states of MD, PA, TN and TX.

Code Information

Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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