Recall Z-2180-2021
Tenderneeds Fertility LLC · initiated December 23, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Codes / lots: All lots sold prior to December 9, 2019.
Reason for recall
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
FDA-determined 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. 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 the firm prior to December 9, 2019 are subject to the recall. Some of the products listed in the notice were not previously captured by FDA's summary. This event (RES 88225) was created to document these additional products.
Details
- Recall number
- Z-2180-2021
- Initiated
- December 23, 2020
- Product code
- MQF – Catheter, Assisted Reproduction
- Quantity
- Unknown
- Distribution
- Worldwide distribution.
- Recalling firm
- Tenderneeds Fertility LLC, Greenville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2175-2021 Class II | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2176-2021 Class II | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuiktDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2177-2021 Class II | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU…Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2178-2021 Class II | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSWDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2179-2021 Class II | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2181-2021 Class II | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy &…Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2182-2021 Class II | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |
| Z-2183-2021 Class II | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknownDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | 12/23/2020Open, Classified |