Recall Z-0411-06 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
| Date | Jan 28, 2006 (initiated Nov 7, 2005) |
| Status | Terminated |
| Reason | Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the |
| Quantity | 3,141 pumps |
| Distribution | Nationwide, and internationally in France, Germany, Sweden and teh 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 |