Recall Z-1179-2016— CareFusion 303, Inc.

Name: FDA recall Z-1179-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-15

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-02-15, terminated 2016-10-24. It names one FDA 510(k) clearance: K944320. Product: Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007. Reason: CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-15
Terminated: 2016-10-24
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K944320 — VENTED/NON-VENTED GEMINI ADMINISTRATION SETImed Corp.·cleared 1995-02-14

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

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

Reason for recall

CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

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