Stradis Healthcare recalls cotton applicators with incomplete bag sealing that could breach sterility during medical procedures. Affected items have specific serial numbers and item numbers.
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 cotton applicators that may have incomplete bag seals, risking sterility breaches during medical procedures. This could lead to infections if used improperly.
The outer bag may not seal properly during manufacturing, potentially allowing contamination. If the kit is used without the sterility being intact, it could lead to infections during medical procedures.
Healthcare professionals and patients using the recalled cotton applicators for medical procedures. Those with the specific serial numbers or item numbers are most at risk.
Check for item number 505-010, serial numbers starting with 22269491064, or UDI/DI codes M7525050101 (case) and M7525050100 (kit).
Identify the item number (505-010), serial numbers (starting with 22269491064), or UDI/DI codes (M7525050101 for case, M7525050100 for kit).
The cotton applicators may have incomplete bag seals during manufacturing, which could breach sterility and lead to infections during medical procedures.
The recall record does not specify a remedy, so contact Stradis Healthcare directly for guidance.
Check for item number 505-010, serial numbers starting with 22269491064, or UDI/DI codes M7525050101 (case) and M7525050100 (kit).
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0498-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0498-2023 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.
