FDAFDA · Food and drugs·Recall number Z-1634-2014
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Published May 28, 2014 · Recall initiated: May 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- one customer in IA
- Lot
- Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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