Recall Z-0661-03 ยท FKP System, Dialysate Delivery, Single Patient
Baxter Healthcare Corp.
Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Mar 20, 2003 (initiated Feb 20, 2003) |
| Status | Terminated |
| Reason | Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP) |
| 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. A |
| 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 Kon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883111 | HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 Baxter Healthcare Corp, Feb 8, 1989 |