Reported Jan 29, 2025 · Ongoing

Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number:…

Trinity Sterile, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trinity Sterile, Inc. · 201 Kiley Dr · Salisbury, MD · 21801-2249

Is this the product you have?

  • Brand NameWolf-Pak
  • Product NamePremium Dressing Change Kit with GuardiVa &
  • Statlock CS/30 Model/Catalog NumberDC5090LF
  • Software VersionN/A
  • Product Description
    • Dressing change kit
    • case of 30
    • lot #600088
    • 198 cases affected
  • ComponentNo
Lot codes and dates
    • Model No DC5090LF
    • UDI-DI 10850007185722
    • Lot Number 600088
Amount recalled
5,940 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.