Recall Z-0931-2014— CareFusion 303, Inc.

Name: FDA recall Z-0931-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-16

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2014-01-16, terminated 2014-08-06. It names one FDA 510(k) clearance: K051499. Product: Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.. Reason: CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-16
Terminated: 2014-08-06
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051499 — INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETMedegen Medical Manufacturing Services·cleared 2005-06-22

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

Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

Reason for recall

CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

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