RecallRadar

FDA Device recall Z-1549-2022

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

On 2022-08-24 the FDA classified a Class II recall of Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF by Trinity Sterile, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1549-2022
ClassificationClass II
Statusterminated
Initiated2022-06-29
Published2022-08-24
Last updated2026-09-13 11:56 UTC
CompanyTrinity Sterile
DistributionUS

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1549-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.