FDA recall Z-1355-2021

Product

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.

Distribution

World-wide distribution.

Key facts

Status

Ongoing

Initiation date

2020-12-23

Report date

2021-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2021