Medical device recalls Moderate risk

Trinity Sterile, Inc. recalls Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5…

Recall date
December 13, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1015-2025
FDA classification
Class II
Brand / firm
Trinity Sterile, Inc.
Sold / distributed
US Nationwide distribution in the states of MD, PA, TN and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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