Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 1,980

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.

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 →

Same manufacturer · Trinity Sterile, Inc.

See all →

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Dressing Change Tray Recalled Due to Potential Package Sterility Compromise
FDA (Devices) · 2025-01-29
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Dressing Change Kit Recalled Due to Package Integrity Concern
FDA (Devices) · 2025-01-29
High
Dressing Change Kits Recalled for Potential Package Sterility Compromise
FDA (Devices) · 2025-01-29
High
Dressing change kits recalled due to packaging defect compromising sterility
FDA (Devices) · 2025-01-29
High
Medical Dressing Kit Recalled for Mislabeled Latex Content
FDA (Devices) · 2022-08-24

Same hazard · sterility compromise