Tenderneeds Fertility LLC recalls unapproved artificial insemination kits due to lack of marketing authorization. Affected kits may pose risks if used without proper regulatory approval.
Device was distributed without a proper marketing authorization.
Tenderneeds Fertility LLC is recalling two specific artificial insemination kits because they were distributed without proper regulatory approval. This could lead to medical risks if used without the necessary authorizations.
The kits were distributed without proper regulatory approval, meaning they may not meet safety and efficacy standards. This could result in medical complications if used without the required authorizations.
Women and healthcare providers using the recalled kits for fertility treatments. Those who have purchased the kits without proper authorization are most at risk.
Check for the SKU numbers 636391205962 or 636391206013 on the kit packaging. All lots of these kits are affected.
Verify the SKU numbers on the packaging to confirm if the kit is affected.
The kits were distributed without proper marketing authorization, which may not meet safety and efficacy standards.
The official recall notice does not specify a remedy, so contact Tenderneeds Fertility LLC directly for guidance.
The recall indicates a lack of regulatory approval, which could pose medical risks if used without proper authorization.
We’ve drafted a message you can send Tenderneeds to request your refund or repair — edit it as you like.
Subject: Recall Z-1362-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-1362-2021 from Tenderneeds. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
