Recall Z-0152-2009 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. Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.
| Date | Oct 21, 2008 (initiated Sep 5, 2008) |
| Status | Terminated |
| Reason | Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for |
| Quantity | 509 units |
| Distribution | Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea. |
| 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 |