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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:192759

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.

Official recall number

Z-1004-2022

Evidence summary

Product code
OHM
Recall status
Terminated
Event initiated
March 18, 2022
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1004-2022