Z-0485-2018Class II

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

Name: Z-0485-2018 Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation...
Creator: Baxter Healthcare Corporation
Published: 2017-07-27
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2017-07-27 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures on 2017-07-27. FDA classified it as Class II and gives the reason as "A leak may allow for microbial contamination of the sterile fluid path". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0485-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Posted: 2018-01-11
Terminated: 2020-11-03
Recalling firm: Baxter Healthcare Corporation
Product: Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Product code: KPE Container, I.V.
Reason for recall: A leak may allow for microbial contamination of the sterile fluid path.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837.
Quantity in commerce: 29,088 units
Distribution: Distribution in the US and Canada.
Product codes and lots: Product Code 2J8003, Lot No. DR16J18096.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0485-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0485-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-29

Product code KPE

K964853Class IIIntravia Container, EmptyBaxter Healthcare Corp / cleared 1997-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)