Z-1030-2010

Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation

Name: Z-1030-2010 Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation
Creator: Baxa Corporation
Published: 2009-11-12
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2009-11-12 / Terminated / root cause: manufacturing process

FDA source

Baxa Corporation began a recall of Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation on 2009-11-12. The reason FDA records is "TPN bags may leak fluid due to inadequate sealing". 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-1030-2010
Status: Terminated
Initiated: 2009-11-12
Posted: 2010-03-09
Terminated: 2011-02-24
Recalling firm: Baxter Corporation Englewood
Product: Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
Product code: KPE Container, I.V.
Reason for recall: TPN bags may leak fluid due to inadequate sealing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292.
Quantity in commerce: 646/50 bag cases
Distribution: Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.
Product codes and lots: Lot numbers: 738391, 738392.

Product code KPE

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)