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Open, Classified

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

FDA Recall Z-1362-2021 · Posted None

Recalling FirmTenderneeds Fertility LLC
Recall StatusOpen, Classified
Product CodeMQF
Date Initiated2020-12-23
Product QuantityUnknown

Reason for Recall

Device was distributed without a proper marketing authorization.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

World-wide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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