10 results
·
48ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·April 28, 2021
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025