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U.S. Department of Health and Human Services

Class 2 Device Recall NPT7 analyzer cartridges

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 Class 2 Device Recall NPT7 analyzer cartridgessee related information
Date Initiated by FirmMay 01, 2006
Date PostedJuly 27, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall NumberZ-1261-06
Recall Event ID 35698
510(K)NumberK982928 
Product Classification blood gas analyzer - Product Code CHL
ProductDri-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
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
ActionThe 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 Commerce185
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CHL
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