Date Initiated by Firm | May 01, 2006 |
Date Posted | July 27, 2006 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number | Z-1261-06 |
Recall Event ID |
35698 |
510(K)Number | K982928 |
Product Classification |
blood gas analyzer - Product Code CHL
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Product | Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device. |
Code Information |
D7120 946-003 Cartridges, Lot #R0299, Expiration Date: 02/2008. |
Recalling Firm/ Manufacturer |
Radiometer America Inc 810 Sharon Dr Westlake OH 44145-1598
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For Additional Information Contact | 440-871-8900 |
Manufacturer Reason for Recall | Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark. |
FDA Determined Cause 2 | Other |
Action | The recalling firm initiated this recall with a letter to send to their customers, via Registered Mail, on 5/1/2006. The letter requests that the customers identify and discard the potentially defective cartridges from Lot #R0299. The letter is accompanied by a recall response page to be completed by the customer and faxed or mailed back to the Radiometer so that the customer can receive an equal number of replacement cartridges free-of-charge. |
Quantity in Commerce | 185 |
Distribution | Nationwide. |
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
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