The Recall Desk
HighFDA (Devices)·Z-1013-2025·Announced 2025-01-29

Wolf-Pak Dressing Change Kits Recalled Due to Package Defects

Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

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 Class II recall involves a potential breach of package sterility on a medical device used for wound care. While the hazard is theoretical without reported illnesses or injuries, the risk to sterile medical devices meets the High severity threshold for risk-of-harm products under FDA recall criteria.

Plain-English summary

Trinity Sterile, Inc. is recalling Wolf-Pak Dressing Change Kits with Transparent Dressing & 3mL CHG One Step Applicator (Model DC3077LF) due to defects in the product packaging. The recalled items are from lot #600018 and comprise 1,980 units (66 cases of 30 units each).

The defect involves a potential for holes to develop in the package, which could compromise the sterility of the medical kit. The product is intended as a sterile dressing change kit, and any breach in package integrity could jeopardize the sterility assurance needed for safe use.

The affected products were distributed nationwide in Maryland, Pennsylvania, Tennessee, and Texas. This is an FDA Class II recall.

Healthcare facilities and individuals who have purchased or received these products should stop using them and contact Trinity Sterile, Inc. for instructions on return or replacement.

The recalled product

Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Manufacturer
Trinity Sterile, Inc.
Category
Medical Device — Wound Care / Dressing Kit
Hazard
  • sterility-compromise
  • package-defect

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 DC3077LF
  • UDI-DI 10857800006841
  • Lot Number 600018

Distribution

Distributed nationwide across the United States.

Related recalls

Same category