Devices

Device Recall Diametrics Medical IRMA

Model / Serial
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.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
Product Description
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).
Manufacturer
Diametrics Medical, Inc.
1 Event
- Recall of Device Recall Diametrics Medical IRMA

Manufacturer

Diametrics Medical, Inc.

Manufacturer Address
Diametrics Medical, Inc., 2658 Patton Road, Roseville MN 55113
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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