Recall Z-0550-06 ยท MEA Pump, Infusion, Pca
Baxter Healthcare Corp.
AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Apr 26, 2006 (initiated Oct 27, 2005) |
| Status | Terminated |
| Reason | When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 10/27/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for air to migrate through the silicone-pumping segment of the sets, which may result in air reaching the patient. Baxter recommended that the users of the I-Pump to enable the upstream occlusion sensor of the pump or to use sets containing air-elimination filters if the occlusion sensor is disabled or otherwise not activated. Baxter also recommended that for delivery routes other than epidural and subcutaneous at flow r |
| Quantity | 20,470 pumps |
| Distribution | Nationwide, including Puerto Rico, and internationally to Canada, Chile and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926385 | BARD APII PUMP C.R. Bard, Inc., Apr 18, 1994 |