Home / Recalls / Tenderneeds Fertility LLC / Z-2181-2021

Z-2181-2021 Class II Ongoing

Recalled by Tenderneeds Fertility LLC — Greenville, IN

Recall Details

Product Type
Devices
Report Date
August 11, 2021
Initiation Date
December 23, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

Product Description

Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

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.

Distribution Pattern

Worldwide distribution.

Code Information

All lots sold prior to December 9, 2019.

Other recalls by Tenderneeds Fertility LLC

  • Z-2177-2021 Class II — Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, S (December 23, 2020)
  • Z-2175-2021 Class II — Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 (December 23, 2020)
  • Z-2176-2021 Class II — Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU (December 23, 2020)
  • Z-2178-2021 Class II — Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW (December 23, 2020)
  • Z-1361-2021 Class II — Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) (December 23, 2020)
  • Z-2180-2021 Class II — TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 13316 (December 23, 2020)
  • Z-2179-2021 Class II — 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 1432985929 (December 23, 2020)
  • Z-2182-2021 Class II — Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 (December 23, 2020)
  • Z-2183-2021 Class II — 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU (December 23, 2020)
  • Z-1355-2021 Class II — At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894 (December 23, 2020)