FDA Medical Device Recalls (openFDA)
Trinity Sterile, Inc.: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
- Recall number
- Z-1551-2022
- Recalling firm
- Trinity Sterile, Inc.
- Product
- Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
- Status
- Terminated
- Initiated
- 2022-06-29
- Posted
- not on file
- Terminated
- 2024-05-10
- 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
- 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 customerservice@trinitysterile.com. 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
- 4,169 cases (125,070 eaches)
- Distribution
- US Nationwide distribution in the states of FL, PA.
- Lot, serial or model codes
- UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OXQ
- Firm FEI
- 1000123297
- Firm city
- Salisbury
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28