Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0506-04

AG-920RA Multi-gas unit analyzer

Nihon Kohden America Inc / initiated 2003-12-05 / Terminated / root cause: manufacturing process

Nihon Kohden America Inc began a recall of AG-920RA Multi-gas unit analyzer on . The reason FDA records is "Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0506-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Nihon Kohden America Inc
Product
AG-920RA Multi-gas unit analyzer
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall
Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough.
Root cause tag
manufacturing process
FDA root cause
Other
Action
Consignees were notified on 12/5/03. All have received return authorizations.
Quantity in commerce
24
Distribution
CA, OK, NV
Product codes and lots
Serial numbers 00001 to 00020, 00022, 00023, 00024, 00029.