Stradis Healthcare recalls Vasc Vein procedure trays with potential sterility breaches due to incomplete sealing. Affected items have specific serial numbers and item numbers. Consumers should contact Stradis Healthcare 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 Vasc Vein procedure trays that may have incomplete sealing of the outer bag, risking a breach in sterility. This could lead to infections if used in medical procedures without proper sterilization.
The trays may have outer bags that are not sealed properly during manufacturing. This could allow contamination, leading to a breach in sterility if the kit is used in medical procedures without being properly sterilized.
Healthcare professionals using the Vasc Vein procedure trays for medical procedures. Patients undergoing surgery or procedures with these trays are at risk of infection if the sterility is compromised.
Check for the item number 682-1583, serial numbers starting with 22237491038, or UDI/DI codes M75268215831 (case) and M75268215830 (kit).
Identify the item number, serial numbers, or UDI/DI codes to confirm if your tray is affected.
The affected item number is 682-1583, with serial numbers starting with 22237491038.
The recall indicates the outer bag may not be sealed properly, but there is no visible indicator to check for breaches without testing.
The recall 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-0541-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0541-2023 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.
