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Class 2 Device Recall Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests |
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Date Initiated by Firm |
December 23, 2020 |
Create Date |
August 02, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2176-2021 |
Recall Event ID |
88225 |
Product Classification |
Catheter, assisted reproduction - Product Code MQF
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Product |
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt |
Code Information |
All lots sold prior to December 9, 2019. |
Recalling Firm/ Manufacturer |
Tenderneeds Fertility LLC 10162 Bradford Rd Greenville IN 47124-9227
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For Additional Information Contact |
260-337-8453
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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.
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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
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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.
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