Reported Aug 24, 2022 · Terminated

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

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?

  • Wolf Pak Premium Dressing
  • Change Kit with Statlock CS/30 RefDC5040LF
Lot codes and dates
  • UDI-DI10850007185746
  • Case 00850007185749 Kit Lot Numbers
    • 600000
    • 600001
    • 600002
    • 600003
    • 600004
    • 600005
    • 600008
    • 600009
    • 600010
    • 600011
    • 600012
Amount recalled
2,512 cases (75,360 eaches )

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

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

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

Notice updated May 10, 2024 · Data as of Sep 19, 6:55 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.