Recall Z-1355-2021— Tenderneeds Fertility LLC
Class II · Ongoing
Class II FDA medical device recall by Tenderneeds Fertility LLC, initiated 2020-12-23. FDA's recall record names no specific 510(k) clearance for this event. Product: At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801). Reason: Device was distributed without a proper marketing authorization..
- Recalling firm
- Tenderneeds Fertility LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-12-23
- Firm location
- Greenville, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.