Z-1045-2020Class II

Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S)...

Name: Z-1045-2020 Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S)...
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 PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190... 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-1045-2020
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 PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INSERTION KIT CVI515 VENOUS ACCESS KIT CVI650 INSERTION TRAY
Product code: OFF Central Venous Catheter Tray
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.
Quantity in commerce: 29020
Distribution: Nationwide Foreign: GHANA
Product codes and lots: Kit Code Product Lot Number DM1005 DAILY LVAD MAINTENANCE KIT N 2019030480 DM280A LVAD MANAGEMENT SYSTEM 2-7 2019010790 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT 2018122890 DM380 DAILY LVAD KIT MORRISTOWN MEDICAL 2019061190 DM405A ADVOCATE CHRIST DAILY WET KIT 2019030480 DM405A ADVOCATE CHRIST DAILY WET KIT 2019012980 DM525 LVAD SENSITIVE KIT N 2019040180 DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST 2018111290 DM550 VAD DRIVELINE MANAGEMENT TRAY 2018121790 DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L 2019032290 DM565 LVAD DRESSING SYSTEM Y 2018112890 DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S 2019010490 DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY 2019042980 DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY 2019042280 DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY 2019030480 DM690 VAD DRIVELINE MANAGEMENT BUNDLE 2019011790 DM710 VAD DAILY DRESSING CHANGE KIT 2019011790 DM720 DAILY LVAD MAINTENANCE KIT 2018122190 DM765 DAILY DRIVELINE MANAGEMENT SYSTEM 2018112190 DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM 2018121790 DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT 2019030890 DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT 2019011890 DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM 2019020480 DM870 DAILY MAINTENANCE SYSTEM LVAD 2018102590 DM920 GAUZE DRIVELINE MANAGEMENT KIT 2019031190 DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT 2018111590 DM935 DAILY DRIVELINE MANAGEMENT SYSTEM 2018110790 DM950 HIGH DRAINAGE LVAD TRAY 2019012590

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2020
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 OFF

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)