Z-1420-2012

Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix...

Name: Z-1420-2012 Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix...
Creator: Baxa Corporation
Published: 2009-05-08
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2009-05-08 / Terminated / root cause: labeling and UDI

FDA source

Baxa Corporation began a recall of Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and... on 2009-05-08. The reason FDA records is "Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1420-2012
Status: Terminated
Initiated: 2009-05-08
Posted: 2012-04-13
Terminated: 2012-04-13
Recalling firm: Baxter Corporation Englewood
Product: Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Baxa sent a Customer Notice letter dated May 8, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Current Baxa product is mislabeled as non-DEHP but this does not present a risk to patients. Baxa is committed to providing products that are non-DEHP. We are working with our supplier to replace the spike port with a non-DEHP as soon as possible. In the meantime, product labeling will be updated to reflect this finding. For further questions please call (303) 690-4204.
Quantity in commerce: 347,494 cases/ 50 bags each
Distribution: Worldwide Distribution -- USA (nationwide)
Product codes and lots: Model 137, Size 250 ml, Cat. No. H938 137 3 Model 138, Size 500 ml, Cat No. H938 138 3 Model 139, Size 1000 ml, Cat No. H938 139 3 Model 140, Size 2000 ml,Cat. No. H938 140 3 Model 141, Size 3000 ml, Cat. No. H938 141 3 Model 142, Size 4000 ml, Cat. No. H938 142 3 Model 143, Size 5000 ml, Cat. No. H938 143 3 Model 341, Size 500/3000 ml, Cat No. H938 341 3

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)