Home / Recalls / Trinity Sterile, Inc. / Z-1015-2025

Z-1015-2025 Class II Ongoing

Recalled by Trinity Sterile, Inc. — Salisbury, MD

FDA device recall Z-1015-2025 was initiated by Trinity Sterile, Inc. on December 13, 2024 and is designated Class II. Reason for recall: Potential for hole in package compromising sterility of the medical kit. The recall status is ongoing. Affected quantity: 5,940 units.

Recall Details

Product Type: Devices
Report Date: January 29, 2025
Initiation Date: December 13, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,940 units

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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

Other recalls by Trinity Sterile, Inc.

Z-1014-2025 Class II — Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegade (December 13, 2024)
Z-1013-2025 Class II — Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressin (December 13, 2024)
Z-1012-2025 Class II — Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL (December 13, 2024)
Z-1016-2025 Class II — Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/ (December 13, 2024)
Z-1550-2022 Class II — Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF (June 29, 2022)
Z-1549-2022 Class II — Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF (June 29, 2022)
Z-1551-2022 Class II — Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090 (June 29, 2022)
Z-1548-2022 Class II — Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 (June 29, 2022)
Z-1468-2021 Class II — Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to (February 23, 2021)