Z-0660-03

Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division...

Name: Z-0660-03 Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division...
Creator: Baxter Healthcare Corp.
Published: 2003-02-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2003-02-20 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015 on 2003-02-20. The reason FDA records is "Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0660-03
Status: Terminated
Initiated: 2003-02-20
Posted: 2003-03-20
Terminated: 2006-03-27
Recalling firm: Baxter Healthcare Corporation
Product: Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015
Product code: FKP System, Dialysate Delivery, Single Patient
Reason for recall: Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)
FDA root cause: Other
Action: Baxter sent Safety Alert letters dated 2/20/03 to the end users, informing them of the possibility of either excess or insufficient ultrafiltration when the operator manually controls ultrafiltration via adjustment of transmembrane pressure. The accounts were informed that turning off the UF controller during fault codes FL-04, FL-07 and FL-08 may affect the ability to safely perform manual ultrafiltration, and that treatment should be discontinued if those three fault codes are displayed. Changes to the instructions for use are in process and will be sent to the end users when completed. Additionally, the Baxter 1550 has a side panel that contains a 16-digit display. Currently, during all ultrafiltration system fault modes the display indicates 'Manual UF Control'. To avoid operator confusion, new software is being developed that will provide a display of 'Discontinue TX' when a FL-04, FL-07 or FL-08 fault code occurs. The SPS 550 does not have the side panel display and does not require the software upgrade.
Distribution: Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, Venezuela and Vietnam.
Product codes and lots: catalog numbers 5M1309, 5M1309R, 5M1310, 5M1310R, 5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R, 5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714, FM4796R, FM4797;all serial numbers

Product code FKP

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)