Recall Z-0085-2015— Baxter Healthcare Corp

Name: FDA recall Z-0085-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-16

Class I · Terminated

Class I FDA medical device recall by Baxter Healthcare Corp, initiated 2014-09-16, terminated 2017-06-21. It names one FDA 510(k) clearance: K964853. Product: Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.. Reason: Particulate matter found inside the fluid path..

Recalling firm: Baxter Healthcare Corp
Classification: Class I
Status: Terminated
Initiated: 2014-09-16
Terminated: 2017-06-21
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K964853 — INTRAVIA CONTAINER, EMPTYBaxter Healthcare Corp·cleared 1997-03-31

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 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.

Reason for recall

Particulate matter found inside the fluid path.

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