Centurion Medical Products Corporation: 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

Recall number

Z-1094-2020

Recalling firm

Centurion Medical Products Corporation

Product

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

Status

Terminated

Initiated

2019-12-11

Posted

not on file

Terminated

2020-09-04

Reason

Incomplete seals on the sterile package may compromise the sterility

Root cause

Packaging process control

Action

Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

Quantity

not on file

Distribution

Nationwide Foreign: GHANA

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRP

Firm FEI

3008403546

Firm city

Williamston

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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