Class 2 Device Recall Premium At Home Pro Series Insemination Kit

• Date Initiated by Firm: December 23, 2020
• Create Date: April 06, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1360-2021
• Recall Event ID: 87581
• Product Classification: Catheter, assisted reproduction - Product Code MQF
• Product: Premium At Home Pro Series Insemination Kit (SKU 644042787927)
• Code Information: All lots
• Recalling Firm/ Manufacturer: Tenderneeds Fertility LLC; 10162 Bradford Rd; Greenville IN 47124-9227
• For Additional Information Contact: 260-337-8453
• Manufacturer Reason for Recall: Device was distributed without a proper marketing authorization.
• FDA Determined Cause: No Marketing Application
• Action: On December 23, 2020, the firm published a recall notification on its website at the following URL: https://tenderneedsfertility.com/recalls The notification notified customers that all IUI and ICI kits sold for human use were being recalled. Customers were instructed to destroy these products, including leftover portions, immediately. The firm did not ask customers to return the product.
• Quantity in Commerce: Unknown
• Distribution: World-wide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.