Home / Recalls / Trinity Sterile, Inc. / Z-1468-2021

Z-1468-2021 Class II Terminated

Recalled by Trinity Sterile, Inc. — Salisbury, MD

Recall Details

Product Type
Devices
Report Date
April 28, 2021
Initiation Date
February 23, 2021
Termination Date
February 16, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2970 units

Product Description

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

Reason for Recall

Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

Distribution Pattern

US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.

Code Information

Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001

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-1015-2025 Class II — Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & (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)