Z-1197-2010

Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation...

Name: Z-1197-2010 Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation...
Creator: Baxa Corporation
Published: 2010-02-10
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2010-02-10 / Terminated / root cause: manufacturing process

FDA source

Baxa Corporation began a recall of Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding... on 2010-02-10. The reason FDA records is "Molding defect in the valve body causes leaking". 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-1197-2010
Status: Terminated
Initiated: 2010-02-10
Posted: 2010-03-23
Terminated: 2012-04-09
Recalling firm: Baxter Corporation Englewood
Product: Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Molding defect in the valve body causes leaking.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242.
Quantity in commerce: 3230 cases; 32300 units (10 units/case)
Distribution: Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD.
Product codes and lots: Model number: 724, Lot Numbers: 740789 through 742707 (sequentially numbered).

Product code LHI

K002705Class IIExacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. / cleared 2001-03-28

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)