Trinity Sterile, Inc.

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1016-2025Class IIBrand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM61December 13, 2024
Z-1015-2025Class IIBrand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 ModeDecember 13, 2024
Z-1014-2025Class IIBrand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHDecember 13, 2024
Z-1013-2025Class IIBrand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One StepDecember 13, 2024
Z-1012-2025Class IIBrand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/December 13, 2024
Z-1549-2022Class IIWolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LFJune 29, 2022
Z-1548-2022Class IISklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708June 29, 2022
Z-1551-2022Class IIWolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LFJune 29, 2022
Z-1550-2022Class IIWolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LFJune 29, 2022
Z-1468-2021Class IIMidline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascFebruary 23, 2021