Recall Z-0376-04 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
| Date | Jan 29, 2004 (initiated Dec 17, 2003) |
| Status | Terminated |
| Reason | Premature motor failure. |
| Root cause | Other |
| Action | Baxter sent letters dated 12/17/03 to all Baxter 6060 Multi-Therapy Infusion Pump accounts that received pumps manufactured with the affected motors or who had their pumps refurbished with affected motors. The letters included a list of affected pump serial numbers for each facility. The accounts were informed of the possible premature motor failure, and were requested to contact Baxter via fax to schedule a service call to correct the pumps. |
| Quantity | 188 units |
| Distribution | The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002679 | 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 Baxter Healthcare Corp, Sep 18, 2000 |