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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:183844

Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).

Official recall number

Z-0065-2021

Evidence summary

Product code
OEQ
Recall status
Terminated
Event initiated
September 14, 2020
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0065-2021

Field note

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