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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:196009

Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.

Official recall number

Z-0082-2023

Evidence summary

Product code
KDI
Recall status
Open, Classified
Event initiated
September 14, 2022
Root cause
Error in labeling
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0082-2023