Device product
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Z-1355-2021
Product summary
- Event
- Event 87581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
device-enforcement:Z-1355-2021
Official wording
Reason: Device was distributed without a proper marketing authorization.
Code information: All lots
Distribution pattern: World-wide distribution.
Derived failure modes
-
Unknown
Device was distributed without a proper marketing authorization.