Recall Z-1570-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Lock Box for 250 mL Container, for use with 6060 Pump Family; Baxter product code 2L9363 and previously marketed by Sabratek under product code 606160, Baxter Healthcare Corporation, Deerfield, IL 60015; Product code 2L9363 is sold separately and as a component of the 6060 Pain kit, product code 2M9832P.
| Date | Apr 22, 2005 (initiated Sep 1, 2004) |
| Status | Terminated |
| Reason | The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow. |
| Root cause | Other |
| Action | Urgent Device Correction letters dated 9/1/04 were sent to all U.S. Baxter affected customers on the same date, to the attention of the Director of Nursing. The facilities were advised of the free-flow incident and as a result that Baxter wanted to heighten awareness of the proper clinical procedures for loading the sets into the infusion systems using these Lock Boxes with the 6060 Multi-Therapy Pump. Baxter''s investigation into the event confirmed that the 6060 pump door was left open after the lock box was attached to the pump. Baxter provided copie of the instructions for use of the lo |
| Quantity | 846 units |
| Distribution | Nationwide and internationally to Australia, Belgium, Canada, France, Hong Kong, Portugal, Spain and the United Kingdom. |
| 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 |