Recall Z-1355-2021 ยท MQF Catheter, Assisted Reproduction
Tenderneeds Fertility LLC
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
| Date | Dec 23, 2020 |
| Status | Open, Classified |
| Reason | Device was distributed without a proper marketing authorization. |
| Root 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 | Unknown |
| Distribution | World-wide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.