Stradis Healthcare recalls sterile surgical trays with item #570-3070 that may have incomplete bag seals, risking sterility breaches. Affected units include specific UDI/DI and serial 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 sterile surgical trays (item #570-3070) because manufacturing may cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, potentially leading to infections during medical procedures.
The trays may have incomplete bag seals during manufacturing, which could allow contamination. If the seal is broken, the sterile contents inside might become exposed to air or other contaminants, increasing infection risk during procedures.
Healthcare professionals using these trays for medical procedures are most at risk. Patients undergoing surgery with improperly sealed trays could face infection risks.
Check for the item number 570-3070 on the tray. Look for UDI/DI codes: H65857030701 (case) or M75257030700 (kit). Serial numbers 22235491255 or 22241491256 indicate affected units.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your tray is affected.
The trays may have been manufactured with incomplete bag seals, which could breach sterility and increase infection risk during medical procedures.
Check for item number 570-3070, UDI/DI codes H65857030701 (case) or M75257030700 (kit), and serial numbers 22235491255 or 22241491256.
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-0528-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0528-2023 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.
