Trinity Sterile, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1549-2022)

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 Kit with GuardVA Cs/30 Ref: DC5030LF

Product Classification:

Class II

Date Initiated: June 29, 2022

Date Posted: August 24, 2022

Recall Number: Z-1549-2022

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: 1,513 cases (45,390 eaches)

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of FL, PA.

Voluntary or Mandated:

Voluntary: Firm initiated