Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds see related information
Date Initiated by Firm December 23, 2020
Create Date August 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-2183-2021
Recall Event ID 88225
Product Classification Catheter, assisted reproduction - Product Code MQF
Product 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Code Information All lots sold prior to December 9, 2019.
Recalling Firm/
Manufacturer		 Tenderneeds Fertility LLC
10162 Bradford Rd
Greenville IN 47124-9227
For Additional Information Contact
260-337-8453
Manufacturer 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 2		 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 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.
Quantity in Commerce Unknown
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-