Recall Z-1459-2014— CareFusion 303, Inc.

Name: FDA recall Z-1459-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-19

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2014-03-19, terminated 2015-06-06. It names one FDA 510(k) clearance: K960280. Product: SmartSite Extension Set, Model No. 20029E, intravascular administration set.. Reason: Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Terminated: 2015-06-06
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETSY·cleared 1996-04-04

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

SmartSite Extension Set, Model No. 20029E, intravascular administration set.

Reason for recall

Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

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