Device recall

Z-1014-2025: Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border…

FDA device recall · Class II · Trinity Sterile, Inc.

Key facts

Recall number (Z-number) Z-1014-2025
Recall event 96068
Product Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No
Product code OXQ
Recalling firm Trinity Sterile, Inc.
Recall class Class II
Status Open, Classified
FEI number 1000123297

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)