Z-1549-2022Class II

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

Name: Z-1549-2022 Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
Creator: Trinity Sterile, Inc.
Published: 2022-06-29
License: https://open.fda.gov/license/

Trinity Sterile, Inc. / initiated 2022-06-29 / Terminated / root cause: labeling and UDI

FDA source

Trinity Sterile, Inc. began a recall of Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF on 2022-06-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1549-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-29
Posted: 2022-08-18
Terminated: 2024-05-10
Recalling firm: Trinity Sterile, Inc.
Product: Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
Product code: OXQ Dressing Change Tray
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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Trinity Medical issued Urgent Medical Device Correction Letter dated June 30, 2022 via email as a follow-up to the call on 6/29/22. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the affected products and lot numbers identified on the attached spreadsheet. If you have affected stock in inventory, immediately discontinue use and quarantine the products. If you have transferred any of the affected kits to a third party, please communicate this information to them. 2. Notify Trinity. Please complete the enclosed Customer Response Form as soon as possible, indicating whether you understand this medical device correction. Fax it to 410-860-2913 or email it to [email protected]. 3. Relabel the affected product. Once Trinity receives your completed Customer Response Form, Trinity will provide you with brightly colored stickers to attach to each case and kit. If you have any questions, please contact Customer Service at 410-860-5123.
Quantity in commerce: 1,513 cases (45,390 eaches)
Distribution: US Nationwide distribution in the states of FL, PA.
Product codes and lots: UDI-DI: 10850007185760 Case 00850007185763 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600006 600007 600008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1549-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1548-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-24	2022-08-18
Z-1549-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-24	2022-08-18
Z-1550-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-24	2022-08-18
Z-1551-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-24	2022-08-18

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)