Recall Z-1464-2017— CareFusion 303, Inc.

Name: FDA recall Z-1464-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-20

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2017-02-20, terminated 2017-11-17. It names one FDA 510(k) clearance: K051499. Product: MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305. Reason: CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Terminated: 2017-11-17
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

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

Reason for recall

CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

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