Recall Z-0078-2020— Centurion Medical Products Corporation

Name: FDA recall Z-0078-2020
Creator: U.S. Food and Drug Administration
Published: 2019-04-24

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-04-24, terminated 2020-04-03. It names one FDA 510(k) clearance: K171957. Product: NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535. Reason: Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection..

Recalling firm: Centurion Medical Products Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-04-24
Terminated: 2020-04-03
Firm location: Williamston, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K171957 — MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc.·cleared 2017-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535

Reason for recall

Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.

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