Home / Recalls / Trinity Sterile, Inc. / Z-1012-2025

Z-1012-2025 Class II Ongoing

Recalled by Trinity Sterile, Inc. — Salisbury, MD

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
1,980 units

Product Description

Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 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 IM46062, UDI-DI 10853155008769, Lot Number 600022

Other recalls by Trinity Sterile, Inc.

  • Z-1015-2025 Class II — Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & (December 13, 2024)
  • Z-1014-2025 Class II — Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegade (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-1013-2025 Class II — Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressin (December 13, 2024)
  • Z-1550-2022 Class II — Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF (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-1551-2022 Class II — Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090 (June 29, 2022)
  • Z-1549-2022 Class II — Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF (June 29, 2022)
  • Z-1468-2021 Class II — Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to (February 23, 2021)