Stradis Healthcare recalls IUD insertion kits (Part 935K) due to unconfirmed compliance with design and manufacturing standards. Consumers should contact the company for details.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Stradis Healthcare is recalling IUD insertion kits (Part Number 935K) because they cannot confirm these products meet required design and manufacturing standards. This recall is about quality assurance, not immediate safety risks.
The hazard stems from the manufacturer's inability to confirm that the tenaculum devices meet required design and manufacturing standards. This uncertainty could lead to potential quality issues during medical procedures, though no specific safety risks are described.
Women who use IUD insertion kits with Part Number 935K are likely affected. Those with medical procedures involving these kits may be at slightly higher risk.
Check for the product name 'IUD Insertion Kit' and Part Number 935K. The recall applies to kits sold by Stradis Healthcare.
Reach out to Stradis Healthcare directly for specific recall details and next steps.
Stradis Healthcare cannot confirm that the tenaculum devices meet required design and manufacturing standards.
Contact Stradis Healthcare directly for specific recall details and next steps.
The recall is about quality assurance, not immediate safety risks. No specific injury mechanism is described.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0128-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0128-2022 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.
