Home / Recalls / Tenderneeds Fertility LLC / Z-1355-2021

Z-1355-2021 Class II Ongoing

Recalled by Tenderneeds Fertility LLC — Greenville, IN

Recall Details

Product Type
Devices
Report Date
April 14, 2021
Initiation Date
December 23, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

Product Description

At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)

Reason for Recall

Device was distributed without a proper marketing authorization.

Distribution Pattern

World-wide distribution.

Code Information

All lots

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-2181-2021 Class II — Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregna (December 23, 2020)