Z-1058-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- September 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Centurion- Umbilical Trays 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
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Code Information
Lot Numbers: UVT1045 UMBILICAL ARTERY TRAY 2018100490 UVT1055 UVC KIT 2019021590 UVT1065 UMBILICAL VESSEL CATHETER TRAY 2019060790 UVT170 UMBILICAL VESSEL TRAY W/O CATHETER 2019040180 UVT280 UMBILICAL ARTERY TRAY 2018101890 UVT460 UMBILICAL CATHETER TRAY 2019050690 UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH 2019020190 UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT 2019012880 UVT640 UMBILICAL CATHETER INSERTION TRAY (P/S) 2019042290 UVT665 UMBILICAL VESSEL CATHETER TRAY 2018120590 UVT730 UMBILICAL VESSEL INSERTION TRAY 2019013190 UVT795 UMBILICAL CATH TRAY 2018120690 UVT960A UMBILICAL PICC/INSERTION TRAY 2019041790 UVT960A UMBILICAL PICC/INSERTION TRAY 2018121390 UVT970 CVC/UMBILICAL CATHETER INSERTION TRAY 2019032790