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Trying to get pregnant can be challenging enough for anxious couples, but imagine being sold an artificial insemination kit that contains a device that is supposed to be used only for animals?

This is what Food and Drug Administration inspectors learned when they visited a small Indiana company late last year. Tenderneeds Fertility had sold an insemination kit, which was marketed with the word ‘human,’ without informing a customer that the component devices were “only intended for use in animals,” according to a recent warning letter that the agency sent to the company.


As the FDA noted, “human users of devices intended solely for animals may put the user at risk for infection due to microbial contamination or allergic reaction, irritation, or toxicity to cells due to inappropriate material biocompatibility.” The agency also pointed out the company disparaged competitors for purportedly selling veterinarian devices for women to use, suggesting that Tenderneeds did not do the same thing.

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