FDA recall Z-1065-2020

Centurion Medical Products Corporation · Class II · device

Product

Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE 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-1065-2020