At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Reported: April 14, 2021 Initiated: December 23, 2020 #Z-1355-2021
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.
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 Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801). 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-1355-2021.
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