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).
FDA Recall Z-1072-03 · Posted 2003-07-30
Recalling FirmDiametrics Medical, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-07-14
Date Terminated2004-07-02
Product Quantity103 boxes of 25 cartridges each.
Reason for Recall
An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
Firm Action
The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.
Root Cause
Other
Distribution Pattern
The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
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.