FDA recall Z-1069-2020

Centurion Medical Products Corporation · Class II · device

Product

Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH 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-1069-2020