Z-0412-06

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

Name: Z-0412-06 Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun...
Creator: Baxter Healthcare Corp.
Published: 2005-11-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-11-14 / 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 2005-11-14. The reason FDA records is "Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0412-06
Status: Terminated
Initiated: 2005-11-14
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: Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.
FDA root cause: Other
Action: Baxter sent recall letters dated 11/14/05 to all of their 6060 pump customers on the same date via DHL overnight delivery. The accounts were informed of the reports of failures within the PCA profile and interruptions of therapy in various profiles. Due to the obsolescence of certain critical components, Baxter is conducting a controlled removal of all 6060 pumps from the market. Baxter will coordinate with customers individually to ensure a smooth transition to a substitute device. Baxter provided interim instructions to discontinue use of the PCA profile to avoid over infusion or non-delivery conditions, and to discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm. Baxter representatives telephoned each account within 48 hours of the letter, and visited them within a week to help the customers transition to other infusion pumps. A press release issued on 11/15/05. Baxter sent a follow-up recall letter to the accounts on 6/20/06, informing them that service repairs for the 6060 Infusion Pump will cease after 12/31/06, and compensation requests cannot be processed for pumps received after 12/31/06. Production of sets for the 6060 will cease on 10/1/06, and will not be available after 12/31/06. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the current inventory of 6060 pumps remaining at the facility.
Quantity in commerce: 34,000 pumps
Distribution: Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia.
Product codes and lots: All serial numbers of all product codes

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)