Recall Z-0144-2010 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Hospira Inc
Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, 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
| K853018 | MODEL 3000 OPTICATH COMPUTER Oximetrix, Inc., Jan 13, 1986 |