Z-0411-06

Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun...

Name: Z-0411-06 Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun...
Creator: Baxter Healthcare Corp.
Published: 2005-11-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-11-07 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40... on 2005-11-07. The reason FDA records is "Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0411-06
Status: Terminated
Initiated: 2005-11-07
Posted: 2006-01-28
Terminated: 2007-06-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
Product code: FRN Pump, Infusion
Reason for recall: Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the Power-On Self Test. The accounts were instructed to contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process for the affected 6060 pumps for correction. Baxter sent follow-up letters dated 2/16/06 to the accounts, to the attention of the Director of Biomedical Engineering, informing them that Baxter has sufficient quantities of replacement circuit boards to begin the repairs. The accounts were requested to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement of the circuit board.
Quantity in commerce: 3,141 pumps
Distribution: Nationwide, and internationally in France, Germany, Sweden and teh United Kingdom.
Product codes and lots: product codes 2M9832, 2M9832P and 2M9832R; product codes 606000, 606000-40, 606000-40L, and 606000-40I; 2M9832: serial numbers 501001HR-501263HR, 502001HR-502156HR, 503001HR-503155HR, 505001HR-505210HR, 507001HR-507054HR, 502001HG-502060HG, 503001HG-503048HG, 505001HG-505276HG, 506001HG-506180HG, 501001HJ-501072HJ, 502001HJ-502072HJ, 503001HJ-503060HJ, 504001HJ-504060HJ, 505001HJ-505060HJ, 501001HW-501020HW, 502001HW-502024HW, 501001HF-501012HF, 502001HF-502024HF

Product code FRN

K002679Class II6060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351Baxter Healthcare Corp / cleared 2000-09-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)