The Recall Desk
HighFDA (Devices)·Z-1014-2025·Announced 2025-01-29

Dressing Change Kits Recalled for Potential Package Sterility Compromise

Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device recall involving sterility compromise in dressing kits without reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3). FDA Class II classification with theoretical hazard.

Plain-English summary

Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (Model DC3080LF) due to a potential for holes in the package that could compromise the sterility of the medical kit.

The recall affects lot #600022, which includes 132 cases (3,960 units total). These products were distributed nationwide in Maryland, Pennsylvania, Tennessee, and Texas.

Compromised sterility in a medical dressing change kit could lead to contamination and increased risk of infection during wound care. Healthcare facilities and consumers should stop using affected kits and contact Trinity Sterile or their distributor for replacement or guidance.

No illnesses or injuries have been reported in connection with this recall. The action is based on the potential for sterility compromise detected in the affected lot.

The recalled product

Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
Manufacturer
Trinity Sterile, Inc.
Category
Medical Device — Sterile Dressing Kit
Hazard
Affected units
3,960

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No DC3080LF
  • UDI-DI 10857800006872
  • Lot Number 600022

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Trinity Sterile, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Trinity Sterile, Inc.

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Same hazard · sterility compromise

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