Recall Z-0485-2018— Baxter Healthcare Corporation

Name: FDA recall Z-0485-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-27

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2017-07-27, terminated 2020-11-03. It names one FDA 510(k) clearance: K964853. Product: Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.. Reason: A leak may allow for microbial contamination of the sterile fluid path..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Terminated: 2020-11-03
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

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

Reason for recall

A leak may allow for microbial contamination of the sterile fluid path.

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