—#85111

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.

FDA product code: dxg
510(k) numbers: K932414
Affected lot / code info: AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003

Why it was recalled

Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Hospira Inc

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2009-08-11
Posted by FDA: 2009-11-09
Terminated: 2012-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.