Deluxe At-Home Human Artificial Intracervical recall
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Why was Deluxe At-Home Human Artificial Intracervical recalled?
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots sold prior to December 9, 2019.
- Product
- Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
- Recalling firm
- Tenderneeds Fertility LLC
- Quantity
- Unknown
- Distribution
- Worldwide distribution.
- Recall date
- August 11, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)