Home / Recalls / Trinity Sterile, Inc. / Z-1549-2022

Z-1549-2022 Class II Terminated

Recalled by Trinity Sterile, Inc. — Salisbury, MD

Recall Details

Product Type
Devices
Report Date
August 24, 2022
Initiation Date
June 29, 2022
Termination Date
May 10, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,513 cases (45,390 eaches)

Product Description

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

Reason for Recall

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Distribution Pattern

US Nationwide distribution in the states of FL, PA.

Code Information

UDI-DI: 10850007185760 Case 00850007185763 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600006 600007 600008

Other recalls by Trinity Sterile, Inc.

  • Z-1016-2025 Class II — Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/ (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-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-1015-2025 Class II — Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & (December 13, 2024)
  • 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-1550-2022 Class II — Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF (June 29, 2022)
  • Z-1468-2021 Class II — Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to (February 23, 2021)