Device product
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
Z-1069-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1069-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: TC6282G TRACHEOSTOMY CARE TRAY 2019013190 TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY 2018101690 TC7370 TRACHEOSTOMY KIT 2018121790 TC7450 DISPOSABLE TRACH TRAY 2019011690
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility