Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Summary
The FDA issued a Class II for Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 by Tenderneeds Fertility LLC. Reason: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021..
Details
Source
Device Recall
External ID
Z-2175-2021
Action Date
2021-08-11
Status
Ongoing
Category
device
Product Description
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Lot/Code Info: All lots sold prior to December 9, 2019.
Quantity Affected: Unknown
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
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-12-23
Company
Greenville, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tenderneeds Fertility LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tenderneeds Fertility LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tenderneeds Fertility LLC have FDA actions?
Tenderneeds Fertility LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2175-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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