Trinity Sterile, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1551-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Product Classification:

Class II

Date Initiated: June 29, 2022
Date Posted: August 24, 2022
Recall Number: Z-1551-2022
Event ID: 90625
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

Status: Terminated
Product Quantity: 4,169 cases (125,070 eaches)
Code Information:

UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019

Distribution Pattern:

US Nationwide distribution in the states of FL, PA.

Voluntary or Mandated:

Voluntary: Firm initiated