PlainRecalls
FDA Devices Moderate Class II Ongoing

At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)

Reported: April 14, 2021 Initiated: December 23, 2020 #Z-1357-2021

Product Description

At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)

Reason for Recall

Device was distributed without a proper marketing authorization.

Details

Recalling Firm
Tenderneeds Fertility LLC
Units Affected
Unknown
Distribution
World-wide distribution.
Location
Greenville, IN

Frequently Asked Questions

What product was recalled?
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870). Recalled by Tenderneeds Fertility LLC. Units affected: Unknown.
Why was this product recalled?
Device was distributed without a proper marketing authorization.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1357-2021.