At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
FDA Recall #Z-1357-2021 — Class II — December 23, 2020
Product Description
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Reason for Recall
Device was distributed without a proper marketing authorization.
Recalling Firm
Tenderneeds Fertility LLC — Greenville, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Unknown
Distribution
World-wide distribution.
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated