Recall Z-2687-2016— Baxter Healthcare Corp.

Name: FDA recall Z-2687-2016
Creator: U.S. Food and Drug Administration
Published: 2012-12-14

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2012-12-14, terminated 2016-12-23. It names one FDA 510(k) clearance: K042936. Product: Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.. Reason: Some of the individual extension set packages were improperly sealed, compromising the sterility of the product..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-12-14
Terminated: 2016-12-23
Firm location: Round Lake, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K042936 — SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITEBaxter Healthcare Corp·cleared 2004-11-26

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

Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

Reason for recall

Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

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