Recall Z-0146-2010
Hospira Inc · initiated August 11, 2009
Product
Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 56711-04-03, 5671-04-05, 56711-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Codes / lots: AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003
Reason for recall
Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0146-2010
- Initiated
- August 11, 2009
- Posted by FDA
- November 9, 2009
- Terminated
- April 4, 2012
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Quantity
- 204,999 power cords distributed for all devices
- Distribution
- Worldwide distribution.
- Recalling firm
- Hospira Inc
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0142-2010 | Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | 08/11/2009Terminated |
| Z-0143-2010 | Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | 08/11/2009Terminated |
| Z-0144-2010 | Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | 08/11/2009Terminated |
| Z-0145-2010 | Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | 08/11/2009Terminated |
| Z-0147-2010 | Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | 08/11/2009Terminated |