Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
- Company
- Tenderneeds Fertility Llc
- Recall Initiated
- December 23, 2020
- Recall Number
- Z-1362-2021
- Quantity
- Unknown
- Firm Location
- Greenville, IN
Reason for Recall
Device was distributed without a proper marketing authorization.
Distribution
World-wide distribution.
Lot / Code Info
All lots
Root Cause
No Marketing Application
Action Taken
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.