At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 6...
FDA Recall #Z-1355-2021 — Class II — December 23, 2020
Product Description
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
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