Recall Z-0599-06 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option); Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
| Date | Mar 7, 2006 (initiated Feb 8, 2006) |
| Status | Terminated |
| Reason | 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 | Important Product Information letters dated 2/8/06 were sent to the AS40 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the delay in the detection of a downstream occlusion when the AS40 pump is used with large volume syringes at low flow rates. To minimize the occlusion detection times at low flow rates, Baxter recommended that the customers take the following actions: * Use the smallest possible syringe size for the volume of fluid to be delivered; * Select the low occlusion pressure setting to minimize the detection time; * Utilize |
| Quantity | 17,400 pumps |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940147 | AUTO SYRINGE AS40A INFUSION PUMP Baxter Corp., Apr 15, 1994 |