FDA Device recall Z-1045-2020
Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTIO…
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTIO… by Centurion Medical Products, citing incomplete seals on the sterile package may compromise the sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1045-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-11 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Centurion Medical Products |
| Distribution | US |
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
Reason
Incomplete seals on the sterile package may compromise the sterility
Identifiers
| code_info | Kit Code Product Lot Number DM1005 DAILY LVAD MAINTENANCE KIT N 2019030480 DM280A LVAD…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 S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.