Recall Z-2175-2021 ยท MQF Catheter, Assisted Reproduction
Tenderneeds Fertility LLC
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
| Date | Dec 23, 2020 |
| Status | Open, Classified |
| Reason | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| 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. This event was previously recorded under RES 87851. On June 9, 2021, firm updated recall communication on website to include more information about the recall. All IUI and ICI kits sold for human use by |
| Quantity | Unknown |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.