Trinity Sterile, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1015-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No

Product Classification:

Class II

Date Initiated: December 13, 2024

Date Posted: January 29, 2025

Recall Number: Z-1015-2025

Event ID: 96068

Reason for Recall:

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

Status: Ongoing

Product Quantity: 5,940 units

Code Information:

Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088

Distribution Pattern:

US Nationwide distribution in the states of MD, PA, TN and TX.

Voluntary or Mandated:

Voluntary: Firm initiated