FDAClass IIApril 14, 2021

Professional Clinical Artificial Intrauterine recall

Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

Why was Professional Clinical Artificial Intrauterine recalled?

Device was distributed without a proper marketing authorization.

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

Product
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Recalling firm
Tenderneeds Fertility LLC
Quantity
Unknown
Distribution
World-wide distribution.
Recall date
April 14, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls