Recalls / —

—#26530

Product

Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA

FDA product code

FKP — System, Dialysate Delivery, Single Patient

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K910215

Affected lot / code info

Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764

Why it was recalled

The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03. The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes. These changes will prevent undetected acid-only delivery in the event of a sodium level change

Recalling firm

Firm

Baxter Healthcare Corp. Rt

Address

120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern

The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong Kong, India, Mexico, Philippines, Singapore, South Korea, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.

Timeline

Recall initiated

2003-03-20

Posted by FDA

2003-05-15

Terminated

2004-01-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.