Baxter Healthcare Corp. Rt. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Baxter Healthcare Corp. Rt.
Lot Codes / Batch Numbers
product codes 2L9351, 2L9351P, 2L9351R, 606000-40E and 606000-40EL: all serial numbers
Products Sold
product codes 2L9351, 2L9351P, 2L9351R, 606000-40E and 606000-40EL: all serial numbers
Baxter Healthcare Corp. Rt. is recalling Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, pro due to Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026