Z-1962-2011

ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A...

Name: Z-1962-2011 ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A...
Creator: Baxa Corporation
Published: 2011-03-08
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2011-03-08 / Terminated / root cause: manufacturing process

FDA source

Baxa Corporation began a recall of ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile... on 2011-03-08. The reason FDA records is "TPN bags may leak during filling operation, due to bag manufacturing error". 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-1962-2011
Status: Terminated
Initiated: 2011-03-08
Posted: 2011-04-12
Terminated: 2012-03-23
Recalling firm: Baxter Corporation Englewood
Product: ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: TPN bags may leak during filling operation, due to bag manufacturing error.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.
Quantity in commerce: 50 bags
Distribution: Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela.
Product codes and lots: All codes sold since 7/23/2009.

Product code LHI

K900585Class IITubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. / cleared 1990-04-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)