FDA-Device2020-02-12Class II

Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S) UVT665 UMBILICAL VESSEL CATHETER TRAY UVT730 UMBILICAL VESSEL INSERTION TRAY UVT795 UMBILICAL CATH TRAY UVT960A UMBILICAL PICC/INSERTION TRAY UVT960A U

Centurion Medical Products Corporation

Hazard

Incomplete seals on the sterile package may compromise the sterility

Sold states

Nationwide Foreign: GHANA

Affected count

N/A

Manufactured in

100 Centurion Way, N/A, Williamston, MI, United States

Products

Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S) UVT665 UMBILICAL VESSEL CATHETER TRAY UVT730 UMBILICAL VESSEL INSERTION TRAY UVT795 UMBILICAL CATH TRAY UVT960A UMBILICAL PICC/INSERTION TRAY UVT960A UMBILICAL PICC/INSERTION TRAY UVT970 CVC/UMBILICAL CATHETER INSERTION TRAY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1094-2020

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