Stradis Healthcare recalls Foundation Kit (Part A10) due to unconfirmed compliance with design and manufacturing standards. Consumers should check product details and follow official instructions.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Stradis Healthcare is recalling its Foundation Kit (Part Number A10) because they cannot confirm it was made to the required design and manufacturing standards. This recall matters because the product may not meet safety standards, potentially leading to risks if used improperly.
The recall states that Stradis Healthcare cannot confirm the tenaculum devices in the Foundation Kit were made to required design and manufacturing standards. This means the product might not be safe for use, especially in medical procedures where precision is critical.
Users of the Foundation Kit (Part Number A10) who purchased it from Stradis Healthcare are affected. Medical professionals using this kit for procedures may be at higher risk if the product does not meet safety standards.
Check for the Foundation Kit with Part Number A10. This product was sold by Stradis Healthcare and may be used in medical procedures.
Identify if your Foundation Kit has Part Number A10.
Stradis Healthcare cannot confirm the tenaculum devices in the Foundation Kit were produced according to required design and manufacturing standards.
The recall record does not specify a remedy, so check the official recall notice for next steps.
The recall states that the product may not meet safety standards, but the specific risk is not described in the record.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0130-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0130-2022 from Stradis Healthcare. 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.
