FDA Device

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).

Hazard

An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

What You Should Do

Remedy

The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.

Products

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,
Brand
Diametrics Medical, Inc.
UPC
The lot on the boxes of the product is ALHCB (this is the correct lot) and is incorrectly printed as ALOHC on the packages of the recalled disposable cartridges.

Units Affected

103 boxes of 25 cartridges each.