Z-1044-2020 Class II Terminated
FDA device recall Z-1044-2020 was initiated by Centurion Medical Products Corporation on December 11, 2019 and is designated Class II. Reason for recall: Incomplete seals on the sterile package may compromise the sterility The recall status is terminated (terminated September 4, 2020). Affected quantity: 957.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- September 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 957
Product Description
Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC LINE TRAY CVI4235 NEONATAL PROCEDURE PICC TRAY CVI4395A NICU PICC INSERTION KIT CVI4395A NICU PICC INSERTION KIT CVI4565 NEONATAL PICC TRAY
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Code Information
Kit Code Product Lot Number CVI2310 NEONATAL PICC INSERTION TRAY 2018122190 CVI2550 NEONATAL PICC INSERTION TRAY 2019061190 CVI2550 NEONATAL PICC INSERTION TRAY 2019020190 CVI2550 NEONATAL PICC INSERTION TRAY 2019010490 CVI2550 NEONATAL PICC INSERTION TRAY 2018101190