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U.S. Department of Health and Human Services

Class 2 Device Recall Gas analyzer

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 Class 2 Device Recall Gas analyzersee related information
Date Initiated by FirmDecember 05, 2003
Date PostedJanuary 31, 2004
Recall Status1 Terminated 3 on February 17, 2004
Recall NumberZ-0506-04
Recall Event ID 28025
Product Classification Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
ProductAG-920RA Multi-gas unit analyzer
Code Information Serial numbers 00001 to 00020, 00022, 00023, 00024, 00029.
FEI Number 2080783
Recalling Firm/
Manufacturer		 Nihon Kohden America Inc
90 Icon
Foothill Ranch CA 92610-3000
For Additional Information ContactSerrah Namini
949-580-1555 Ext. 4401
Manufacturer Reason
for Recall		Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough.
FDA Determined
Cause 2		Other
ActionConsignees were notified on 12/5/03. All have received return authorizations.
Quantity in Commerce24
DistributionCA, OK, NV
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.
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