Stradis Healthcare recalls vein procedure trays with potential sterility breaches due to incomplete sealing. Affected items have specific serial numbers and UDI codes. Consumers should contact the company for details.
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 vein procedure trays that may have incomplete sealing of the outer bag, risking sterility breaches. This could lead to infections if the kits are used without proper sterility.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the kit and increasing infection risk during medical procedures.
Healthcare professionals using the recalled vein procedure trays are most at risk. Patients receiving procedures with these kits could face infection risks if sterility is compromised.
Check for the serial number 22230490618 or UDI codes M7526825771 (case) and M7526585770 (kit) on the product packaging.
Look for the serial number 22230490618 or UDI codes M7526825771 (case) and M7526585770 (kit) on the product packaging.
The trays may have incomplete sealing of the outer bag, which could breach sterility and increase infection risk during medical procedures.
Check for the serial number 22230490618 or UDI codes M7526825771 (case) and M7526585770 (kit) on the product packaging.
The recall does not specify a remedy, so contact Stradis Healthcare directly 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-0551-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0551-2023 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.