Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Recalled by Trinity Sterile, Inc. Due to Mislabeling

Date: June 29, 2022
Company: Trinity Sterile, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Trinity Sterile, Inc. directly.

Affected Products

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

Quantity: 4,169 cases (125,070 eaches)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Trinity Sterile, Inc.

Trinity Sterile, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report