Z-1094-2020Class II

Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170...

Name: Z-1094-2020 Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170...
Creator: Centurion Medical Products Corporation
Published: 2019-12-11
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2019-12-11 / Terminated / root cause: packaging

FDA source

Centurion Medical Products Corporation began a recall of Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL... on 2019-12-11. FDA classified it as Class II and gives the reason as "Incomplete seals on the sterile package may compromise the sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1094-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-02-05
Terminated: 2020-09-04
Recalling firm: Centurion Medical Products, LP
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
Product code: LRP Tray, Surgical
Reason for recall: Incomplete seals on the sterile package may compromise the sterility
Root cause tag: packaging
FDA 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.
Distribution: Nationwide Foreign: GHANA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1094-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1042-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1043-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1044-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1045-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1046-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1047-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1048-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1049-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1050-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1051-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1052-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1053-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1054-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1055-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1056-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1057-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1058-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1059-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1060-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1061-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1062-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1063-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1064-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1065-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1066-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1067-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1068-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1069-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1070-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1071-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1072-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1073-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1074-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1075-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1076-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1077-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1078-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1079-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1080-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1081-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1082-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1083-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1084-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1085-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1086-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1087-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1088-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1089-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1090-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1091-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1092-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1093-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1094-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05
Z-1095-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)