FDA
IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).
An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.