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Centurion Medical Products Corporation

FDA Regulatory Profile

Summary

Total Recalls
152 (2 Class I)
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1069-2020Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7December 11, 2019
Z-1060-2020Class IICenturion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KITDecember 11, 2019
Z-1077-2020Class IICenturion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLEDecember 11, 2019
Z-1070-2020Class IICenturion- Biopsy Tray TRIBT170 BIOPSY TRAYDecember 11, 2019
Z-1056-2020Class IICenturion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC007December 11, 2019
Z-1076-2020Class IICenturion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCIDecember 11, 2019
Z-1090-2020Class IICenturion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAYDecember 11, 2019
Z-1043-2020Class IICenturion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY December 11, 2019
Z-1068-2020Class IICenturion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790December 11, 2019
Z-1086-2020Class IICenturion- LC145 STERILE NICU LINE CHANGE KITDecember 11, 2019
Z-1085-2020Class IICenturion- Port Draw Kit KNV30 PORT DRAW KITDecember 11, 2019
Z-1081-2020Class IICenturion- I86625 DEBRIDEMENT TRAYDecember 11, 2019
Z-1074-2020Class IICenturion-Skin Prep Tray DYNDP1015 SKIN PREP TRAYDecember 11, 2019
Z-1059-2020Class IICenturion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATHDecember 11, 2019
Z-1095-2020Class IICenturion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEDecember 11, 2019
Z-1047-2020Class IICenturion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPADecember 11, 2019
Z-1052-2020Class IICenturion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDUDecember 11, 2019
Z-1062-2020Class IICenturion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSYDecember 11, 2019
Z-1082-2020Class IICenturion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)December 11, 2019
Z-1058-2020Class IICenturion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSELDecember 11, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K161408Compass Cast and MAPNovember 22, 2016
K103562CENTURION PRESSURE INJECTABLE EXTENSION SETJune 23, 2011