Class 2 Device Recall Oximetrix 3 SO2/CO Cardiac Output Computer

• Date Initiated by Firm: August 11, 2009
• Date Posted: November 09, 2009
• Recall Status: Terminated on April 04, 2012
• Recall Number: Z-0144-2010
• Recall Event ID: 53257
• 510(K)Number: K853018
• Product Classification: Computer, Diagnostic, Pre-Programmed, Single-Function - Product Code dxg
• Product: 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.
• Code Information: AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003
• Recalling Firm/ Manufacturer: Hospira Inc
• Manufacturer 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: 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 in Commerce: 204,999 power cords distributed for all devices
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = dxg and Original Applicant = OXIMETRIX, INC.