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Class 2 Device Recall Instrumentation Laboratory (IL) |
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Date Initiated by Firm |
March 07, 2003 |
Date Posted |
May 20, 2003 |
Recall Status1 |
Terminated 3 on May 23, 2012 |
Recall Number |
Z-0846-03 |
Recall Event ID |
25810 |
510(K)Number |
K992834
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Product Classification |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
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Product |
GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
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Code Information |
Lot Number: 306360 Expires: 8/31/2003 |
Recalling Firm/ Manufacturer |
Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington MA 02173
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For Additional Information Contact |
Carol Marble 781-861-4467
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Manufacturer Reason for Recall |
Incorrect bar code applied to cartridges could result in inaccurate pO2 value
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FDA Determined Cause 2 |
Other |
Action |
IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges. |
Quantity in Commerce |
2 |
Distribution |
CA, FL, NY, PA, TN, |
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 = CHL and Original Applicant = INSTRUMENTATION LABORATORY CO.
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