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Class 2 Device Recall Q2 Continuous Cardiac Output (CCO)/SO2 Computer |
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Date Initiated by Firm |
August 11, 2009 |
Date Posted |
November 09, 2009 |
Recall Status1 |
Terminated 3 on April 04, 2012 |
Recall Number |
Z-0145-2010 |
Recall Event ID |
53257 |
510(K)Number |
K932414
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Product Classification |
Computer, Diagnostic, Pre-Programmed, Single-Function - Product Code dxg
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Product |
Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, 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
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = dxg and Original Applicant = ABBOTT LABORATORIES
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