Recall Z-0130-06 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Nov 16, 2005 (initiated Feb 10, 2005) |
| Status | Terminated |
| Reason | Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. |
| Root cause | Other |
| Action | Baxter mailed Urgent Device Correction letters dated 2/10/05 to the domestic accounts on 2/10/05 via first class mail, to the attention of the Director of Nursing, advising them of the following hardware problems and software anomalies and providing workarounds for each. There are potential failures of the pump due to upstream occlusion alarms, electro-static discharge, Key-Only security mode (previously covered by letter dated 4/10/02), system error 32 or 33 codes, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. The accounts were advised that as s |
| Quantity | 24,009 pumps |
| Distribution | Nationwide including Puerto Rico, and internationally through Baxter subsidiaries in Canada, Chile, Hong Kong, Kuwait and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993387 | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K Baxter Healthcare Corp, Nov 1, 1999 |