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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:179123

i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.

Official recall number

Z-1263-2020

Evidence summary

Product code
KHP
Recall status
Terminated
Event initiated
January 15, 2020
Root cause
No Marketing Application
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1263-2020

Field note

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