Stradis Healthcare recalls Perio Surgery trays with item number 20177RPSS 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 Perio Surgery medical trays that may have incomplete bag seals, risking sterility breaches. This could lead to infections if used in procedures without proper sterilization.
The trays' outer bags may not seal properly during manufacturing, creating gaps that allow contamination. This breach could compromise the sterility of the surgical kit, increasing infection risk during procedures.
Healthcare professionals using Perio Surgery trays for dental procedures are most at risk. Patients undergoing surgery with these kits could face infection if the sterility is compromised.
Check for item number 20177RPSS on the tray. Look for UDI/DI codes M75220177RPSS1 (case) or M75220177RPSS0 (kit), and serial numbers starting with 22263491083.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your tray is affected.
The trays may have incomplete bag seals during manufacturing, which could breach sterility and increase infection risk during procedures.
Check for item number 20177RPSS, UDI/DI codes M75220177RPSS1 (case) or M75220177RPSS0 (kit), and serial numbers starting with 22263491083.
The recall record does not specify a remedy, so contact Stradis Healthcare 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-0483-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0483-2023 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.
