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Recall Observatory FDA recall evidence

Device product

At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)

Z-1357-2021

December 23, 2020

Class II

Product summary

Firm
Tenderneeds Fertility LLC
Event
Event 87581
Status
Ongoing
Classification
Class II
Quantity
Unknown
Official record key
device-enforcement:Z-1357-2021

Official wording

Reason: Device was distributed without a proper marketing authorization.

Code information: All lots

Distribution pattern: World-wide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device was distributed without a proper marketing authorization.