Z-0588-2008

Baxter Single Day INFUSOR Portable Elastomeric Infusion System

Name: Z-0588-2008 Baxter Single Day INFUSOR Portable Elastomeric Infusion System
Creator: Baxter Healthcare Corp.
Published: 2007-11-29
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2007-11-29 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter... on 2007-11-29. The reason FDA records is "Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling". 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-0588-2008
Status: Terminated
Initiated: 2007-11-29
Posted: 2008-01-23
Terminated: 2010-04-29
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter on 11/30/07 sent an Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential leaks during filling or use of the infusor. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any clinical/technical questions were directed to the Baxter Healthcare Product Information Center at 1-800-933-0303.
Quantity in commerce: 86,192 units
Distribution: Worldwide: USA, Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Portugal, San Marino, Spain, Sweden, United Kingdom, South Africa, Colombia, Argentina, Hong Kong, Australia and New Zealand.
Product codes and lots: Lot Numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043, 07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074, 07J016, 07J018, 07J052, 07J054, and 07K020

Product code MEB

K062457Class IIInfusor Small Volume Elastomeric Infusion DevicesBaxter Healthcare Corporation / cleared 2006-09-21

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)