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).
This recall has been terminated (originally issued July 30, 2003).
- Company
- Diametrics Medical, Inc.
- Recall Initiated
- July 14, 2003
- Posted
- July 30, 2003
- Terminated
- July 2, 2004
- Recall Number
- Z-1072-03
- Quantity
- 103 boxes of 25 cartridges each.
- Firm Location
- Roseville, MN
- Official Source
- View on FDA website ↗
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.
Distribution
The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
Lot / Code Info
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.
Root Cause
Other
Action Taken
The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.