GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
FDA Recall Z-0846-03 · Posted 2003-05-20
Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeCHL
Date Initiated2003-03-07
Date Terminated2012-05-23
Product Quantity2
Reason for Recall
Incorrect bar code applied to cartridges could result in inaccurate pO2 value
Firm Action
IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
Root Cause
Other
Distribution Pattern
CA, FL, NY, PA, TN,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.