Recall Z-0159-06 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
| Date | Nov 18, 2005 (initiated May 6, 2005) |
| Status | Terminated |
| Reason | A 'Check Flange' alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates. |
| Root cause | Other |
| Action | Urgent Device Correction letters dated 5/5/05 were sent to the AS50 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the false 'Check Flange' alarms due to a combination of certain syringe clamp assemblies on a specific serial numner range of pumps and the dimensional attributes of the Monoject 35 cc syringes. The accounts were requested to check the serial numbers on their AS50 pumps against the listing of serial numbers in the letter and contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the retur |
| Quantity | 10,414 pumps |
| Distribution | Nationwide including Puerto Rico, and internationally to Colombia, Chile, Brazil, Saudi Arabia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945942 | AUTO SYRINGE(R) AS50 INFUSION PUMP Baxter Healthcare Corp, Jul 10, 1995 |