Z-1592-05

Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code...

Name: Z-1592-05 Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code...
Creator: Baxter Healthcare Corp.
Published: 2005-08-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-08-17 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an... on 2005-08-17. The reason FDA records is "Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1592-05
Status: Terminated
Initiated: 2005-08-17
Posted: 2005-09-28
Terminated: 2007-06-19
Recalling firm: Baxter Healthcare Corporation
Product: Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore b) Sabratek 6060 Epidural Pain Management Pump, product codes 606000-40E and 606000-40EL; Manufactured by Sabratek Corp., Skokie, IL 60076, which was purchased by Baxter Healthcare Corp., Deerfield, IL in January 2000.
Product code: FRN Pump, Infusion
Reason for recall: Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher
Root cause tag: software
FDA root cause: Other
Action: Baxter sent the 8/17/05 Urgent Product Recall letter to all Baxter 6060E Infusion Pump customers to inform them of a software anomaly present in software versions 3.00 and higher, which allows the pump to overinfuse in the Auto-Ramp mode. The end users were also informed that these epidural pumps, identified by the yellow housing, can no longer be supported due to a lack of availability of spare parts and Baxter is unable to replace the software with an alternate version. As a result, Baxter requested the accounts to remove the pumps from service and return them to Baxter. The accounts were requested to call Baxter''s Medication Delivery Services at 1-800-843-7867 to arrange for the return of the units and replacement with 6060 Multi-Therapy Infusion Pumps.
Distribution: Nationwide including Puerto Rico, and intenationally to Canada, China, Belgium, Hong Kong and Saudi Arabia
Product codes and lots: product codes 2L9351, 2L9351P, 2L9351R, 606000-40E and 606000-40EL: all serial numbers

Product code FRN

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)