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
Z-1065-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1065-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: Lot Numbers: ID1235A ESKENAZI INCISION & DRAINAGE TRAY 2019020890 ID1525 INCISION & DRAINAGE TRAY 2019052890 ID1670 I&D TRAY 2019050890 ID1715 INCISION & DRAINAGE TRAY 2018121390 ID1765 ER I&D PACK 2019042290 ID1765 ER I&D PACK 2019021190 ID1835 I & D TRAY 2019041290 ID2075 I&D TRAY 2019052990 ID585 INCISION & DRAINAGE TRAY 2019022090 ID875 INCISION & DRAINAGE TRAY 2019020590 ID875 INCISION & DRAINAGE TRAY 2019011790
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility