Recall Z-0147-2010 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Hospira Inc
Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
| Date | Nov 9, 2009 (initiated Aug 11, 2009) |
| Status | Terminated |
| Reason | Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Root cause | Component design/selection |
| Action | Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing. |
| Quantity | 204,999 power cords distributed for all devices |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932414 | CONTINUOUS CARDIAC OUTPUT SYSTEM Abbott Laboratories, Nov 14, 1994 |