FDA recall Z-1045-2020

Centurion Medical Products Corporation · Class II · device

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 for recall

Incomplete seals on the sterile package may compromise the sterility

Distribution

Nationwide Foreign: GHANA

Key facts

Status: Terminated
Initiation date: 2019-12-11
Report date: 2020-02-12
Termination date: 2020-09-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Williamston, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2020