FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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
- Recall number
- Z-0411-06
- Recalling firm
- Baxter Healthcare Corp.
- 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
- Status
- Terminated
- Initiated
- 2005-11-07
- Posted
- 2006-01-28
- Terminated
- 2007-06-19
- Reason
- 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.
- 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
- 3,141 pumps
- Distribution
- Nationwide, and internationally in France, Germany, Sweden and teh United Kingdom.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K002679"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28