Stradis Healthcare recalls vein and laser procedure trays with potential sterility breaches due to incomplete sealing. Affected items have specific serial numbers and item numbers. Consumers should contact the manufacturer 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 and laser procedure trays that may have incomplete sealing of the outer bag, risking a breach in sterility. This could lead to infections if used during medical procedures.
The trays may have outer bags that are not sealed properly during manufacturing. This can cause the sterility of the kit to be compromised, potentially leading to infections during medical procedures.
Healthcare professionals using Stradis Healthcare vein and laser procedure trays with the specific item number 682-334R1 and serial numbers listed. Patients undergoing procedures with these trays are at risk of infection.
Check for item number 682-334R1 on the tray, and serial numbers starting with 22231489619. The UDI/DI (case) is M752682334R11 and UDI/DI (kit) is M752682334R10.
Identify the item number (682-334R1) and serial numbers (starting with 22231489619) on the tray.
The item number is 682-334R1.
Serial numbers starting with 22231489619.
Check for item number 682-334R1 and serial numbers starting with 22231489619.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0548-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0548-2023 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.
