Stradis Healthcare recalls surgery kits with item 682-1728 due to potential sterility breaches from incomplete bag sealing. Affected kits may not be sterile, risking infection during procedures.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling surgery kits that may have incomplete bag sealing, risking sterility breaches. This could lead to infections if used in medical procedures without proper sterilization.
The surgery kits may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, making the kits not sterile when used in medical procedures.
Healthcare professionals and surgical teams using the recalled surgery kits are most at risk. Patients undergoing procedures with these kits could face infection risks.
Check for item number 682-1728 on the kit. Look for UDI/DI codes M75268217281 (case) and M75268217280 (kit), or serial numbers starting with 22235489419.
Verify the item number, UDI/DI codes, and serial numbers to confirm if the kit is affected.
The surgery kits may have outer bags that aren't sealed properly during manufacturing, risking sterility breaches.
Check for item number 682-1728, UDI/DI codes M75268217281 (case) and M75268217280 (kit), or serial numbers starting with 22235489419.
The recall record does not specify a remedy, so contact Stradis Healthcare directly for guidance.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0542-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0542-2023 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.
