Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Trinity Sterile, Inc. with 10 device recalls. The most recent is a device recall dated Dec 13, 2024: Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software VerClass II · Potential for hole in package compromising sterility of the medical kit. | Device recalls |
| Dec 13, 2024 | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software VersioClass II · Potential for hole in package compromising sterility of the medical kit. | Device recalls |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/CatalClass II · Potential for hole in package compromising sterility of the medical kit. | Device recalls |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number:Class II · Potential for hole in package compromising sterility of the medical kit. | Device recalls |
| Dec 13, 2024 | Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product DesClass II · Potential for hole in package compromising sterility of the medical kit. | Device recalls |
| Jun 29, 2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708Class II · Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. | Device recalls |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LFClass II · Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. | Device recalls |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LFClass II · Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
