Recall Z-0221-2016— CareFusion 303, Inc.

Name: FDA recall Z-0221-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-09

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2015-10-09, terminated 2017-03-02. It names one FDA 510(k) clearance: K960280. Product: SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.. Reason: CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-09
Terminated: 2017-03-02
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. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

Reason for recall

CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.

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