FDAClass IIFebruary 12, 2020

Centurion- Uvt1045 Umbilical Artery Tray Uvt1055 UVC recall: Sterility Concern

Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280…

Why was Centurion- Uvt1045 Umbilical Artery Tray Uvt1055 UVC recalled?

Incomplete seals on the sterile package may compromise the sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 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

Product
Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280…
Recalling firm
Centurion Medical Products Corporation
Quantity
N/A
Distribution
Nationwide Foreign: GHANA
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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