Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Reported: August 11, 2021 Initiated: December 23, 2020 #Z-2175-2021
Product Description
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
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.
Details
- Recalling Firm
- Tenderneeds Fertility LLC
- Units Affected
- Unknown
- Distribution
- Worldwide distribution.
- Location
- Greenville, IN
Frequently Asked Questions
What product was recalled? ▼
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001. Recalled by Tenderneeds Fertility LLC. Units affected: Unknown.
Why was this product recalled? ▼
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 11, 2021. Severity: Moderate. Recall number: Z-2175-2021.
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