Recall Z-1044-2020— Centurion Medical Products Corporation

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-12-11, terminated 2020-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Incomplete seals on the sterile package may compromise the sterility.

Recalling firm
Centurion Medical Products Corporation
Classification
Class II
Status
Terminated
Initiated
2019-12-11
Terminated
2020-09-04
Firm location
Williamston, MI, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.