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U.S. Department of Health and Human Services

Class 3 Device Recall reference electrodes

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 Class 3 Device Recall reference electrodessee related information
Date Initiated by FirmSeptember 19, 2005
Date PostedAugust 03, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall NumberZ-1324-06
Recall Event ID 35788
510(K)NumberK041874 
Product Classification reference electrodes - Product Code CHL
ProductReference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.
Code Information Part # 945-633 - Lot #96-02 and Lot #96-03
Recalling Firm/
Manufacturer
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information ContactVince Sigmund
800-736-0600
Manufacturer Reason
for Recall
Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
FDA Determined
Cause 2
Other
ActionFollowing the receipt of three (3) customer complaints, on 9/14/2005, the firm issued an E-Mail notification [Management Cover] to their Service Personnel on 9/19/2005. The Management Cover instructed the service personnel to check the electrodes located at their stock and their customer locations; put all electrodes, which cannot be inserted in their call-back stock; and provide for credit to their customers through normal channels. The Service Personnel in turn, contacted their customers via telephone on or around 9/20/2005 and asked that they check their inventories for the presence of any electrodes which would not fit in the analyzer and return any such electrodes to Radiometer America for replacement
Quantity in Commerce9
DistributionNationwide and Canada.
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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