Recall Z-1549-2022— Trinity Sterile, Inc.

Name: FDA recall Z-1549-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-29

Class II · Terminated

Class II FDA medical device recall by Trinity Sterile, Inc., initiated 2022-06-29, terminated 2024-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF. Reason: 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.

Recalling firm: Trinity Sterile, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-06-29
Terminated: 2024-05-10
Firm location: Salisbury, MD, United States

Product description

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.