Recall Z-0435-2014— CareFusion 303, Inc.

Name: FDA recall Z-0435-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-08

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2013-11-08, terminated 2014-04-17. It names one FDA 510(k) clearance: K944320. Product: VersaSafe Extension Set, Model No. 21000M-007. Reason: CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Terminated: 2014-04-17
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

VersaSafe Extension Set, Model No. 21000M-007

Reason for recall

CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.

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