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Recall Observatory FDA recall evidence

Device product

2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

Z-2183-2021

December 23, 2020

Class II

Product summary

Firm
Tenderneeds Fertility LLC
Event
Event 88225
Status
Ongoing
Classification
Class II
Quantity
Unknown
Official record key
device-enforcement:Z-2183-2021

Official wording

Reason: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Code information: All lots sold prior to December 9, 2019.

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.