Stradis Healthcare recalls IUD insertion packs (Part 618-034) 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 packs with part number 618-034 because they cannot confirm these devices meet required design and manufacturing standards. This recall does not indicate a specific safety risk but highlights a lack of verification in production.
The recall states that Stradis Healthcare cannot confirm the tenaculum devices were made to required standards. This means there might be issues with how the devices are designed or built, but the exact risk is not specified.
Women who use IUD insertion packs with part number 618-034 are likely affected. Those with medical devices requiring precise insertion may be at higher risk.
Check for the part number 618-034 on the IUD insertion pack. The product is sold by Stradis Healthcare.
Reach out to Stradis Healthcare directly for specific instructions on the recall.
The recall does not state a specific injury risk; it only indicates uncertainty about design and manufacturing standards.
Look for the part number 618-034 on the product. Stradis Healthcare is the manufacturer.
Contact Stradis Healthcare directly for specific instructions on the recall.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0127-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0127-2022 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.
