Recall Z-0132-2016— Baxter Healthcare Corp

Name: FDA recall Z-0132-2016
Creator: U.S. Food and Drug Administration
Published: 2015-05-21

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp, initiated 2015-05-21, terminated 2017-05-10. It names one FDA 510(k) clearance: K132734. Product: ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT. Reason: Potential for a leak at the tubing to luer bond..

Recalling firm: Baxter Healthcare Corp
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Terminated: 2017-05-10
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSBaxter Healthcare Corp·cleared 2013-10-08

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

ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

Reason for recall

Potential for a leak at the tubing to luer bond.

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