Stradis Healthcare recalls plastic tenaculum devices due to unconfirmed compliance with design and manufacturing standards. Consumers should check product details for affected units.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Stradis Healthcare is recalling plastic tenaculum devices because they cannot confirm these products meet required design and manufacturing standards. This recall does not indicate a specific safety hazard but addresses potential non-compliance with quality standards.
The recall states that Stradis Healthcare cannot confirm the tenaculum devices were made according to required design and manufacturing standards. This means the devices might not be safe for medical use, potentially leading to complications during procedures.
Medical professionals who use tenaculum devices for surgical procedures may be affected. Patients using these devices are at risk if the devices do not meet quality standards.
The recalled product is a plastic tenaculum with part number 356T. Check if you own this specific model for surgical use.
Identify if your tenaculum device has part number 356T to determine if it is affected.
Stradis Healthcare cannot confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
The recall does not specify a safety hazard; it addresses potential non-compliance with quality standards.
Check if your tenaculum device has part number 356T. If affected, contact Stradis Healthcare for further instructions.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0126-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0126-2022 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.
