Z-0084-2015Class I

Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and...

Name: Z-0084-2015 Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and...
Creator: Baxter Healthcare Corp
Published: 2014-09-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-09-16 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp began a recall of Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is... on 2014-09-16. FDA classified it as Class I and gives the reason as "Particulate matter found inside the 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-0084-2015
Classification: Class I
Status: Terminated
Initiated: 2014-09-16
Posted: 2014-10-31
Terminated: 2017-06-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Product code: KPE Container, I.V.
Reason for recall: Particulate matter found inside the fluid path.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Baxter issued a letter to their consignees stating the following: Baxter is requesting that you take the following actions: Action to be taken if product was purchased directly from Baxter. 1. Locate and remove all affected product from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form , and return it to Baxter by either tax or scanned e-mail. 4. If you distributed any of the affected products to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed product 2B8011 lot U R 13D 15112 to customers between 4/26/2013 and 6/20/2013. Baxter distributed product 2B8013 lot UR13K1 4095 to customers between 11 /27/2013 and 3/ 10/2014. Action to be taken if product was received from an alternate source. 1. Locate and remove all of the affected products from all locations in your facility (the product code and lot numbers can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229- 0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
Quantity in commerce: 94,224
Distribution: Nationwide Distribution including Puerto Rico, and the country of Canada.
Product codes and lots: Product code: 2B8011 Lot Number: UR13D15112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0084-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0084-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31
Z-0085-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31

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)