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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:192841

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.

Official recall number

Z-1005-2022

Evidence summary

Product code
MLS
Recall status
Terminated
Event initiated
March 18, 2022
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1005-2022