Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1015-2025 — 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

U.S. FDA — Device Enforcement · United States · 2024-12-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1015-2025
Date of alert
2024-12-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Trinity Sterile, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10850007185722
Reported risk: Potential for hole in package compromising sterility of the medical kit.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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