Recall Z-0412-06 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 14, 2005) |
| Status | Terminated |
| Reason | Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles. |
| Root cause | Other |
| Action | Baxter sent recall letters dated 11/14/05 to all of their 6060 pump customers on the same date via DHL overnight delivery. The accounts were informed of the reports of failures within the PCA profile and interruptions of therapy in various profiles. Due to the obsolescence of certain critical components, Baxter is conducting a controlled removal of all 6060 pumps from the market. Baxter will coordinate with customers individually to ensure a smooth transition to a substitute device. Baxter provided interim instructions to discontinue use of the PCA profile to avoid over infusion or non-del |
| Quantity | 34,000 pumps |
| Distribution | Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia. |
| 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 |