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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:144408

Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

Official recall number

Z-1369-2016

Evidence summary

Product code
NEP
Recall status
Terminated
Event initiated
March 08, 2016
Root cause
Use error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1369-2016

Field note

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