FDA Medical Device Recalls (openFDA)
Trinity Sterile, Inc.: Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
- Recall number
- Z-1548-2022
- Recalling firm
- Trinity Sterile, Inc.
- Product
- Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
- 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
- 5 cases (125 eaches )
- Distribution
- US Nationwide distribution in the states of FL, PA.
- Lot, serial or model codes
- UDI-DI Number: 50649111317590 Case 10649111317590 Kit Lot Numbers: 600001 600002
- 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