Recall Z-0049-2020— Becton Dickinson & Company

Name: FDA recall Z-0049-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-02

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-05-02, terminated 2021-11-30. It names one FDA 510(k) clearance: K083472. Product: CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C. Reason: After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Terminated: 2021-11-30
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K083472 — MEDEGEN PRESSURE RATED EXTENSION SETSMedegen, Inc.·cleared 2008-12-09

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

CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C

Reason for recall

After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.

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