Stradis Healthcare recalls phlebectomy packs with potential sterility breaches due to incomplete sealing. Affected units have specific serial numbers and item numbers. 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 phlebectomy packs that may have incomplete sealing of the outer bag, risking a breach in sterility. This could lead to infections if used improperly.
The outer bag may not seal properly during manufacturing, which could allow contamination. If the kit is not sterile, it might cause infections during medical procedures.
Medical professionals and patients using the phlebectomy packs for vein removal procedures. Those with specific serial numbers or item numbers are most at risk.
Check for the item number 682-001, serial numbers starting with 22236489633, or UDI/DI codes M7526820011 (case) and M7526820010 (kit).
Look for the item number 682-001, serial numbers starting with 22236489633, or UDI/DI codes M7526820011 (case) and M7526820010 (kit).
The product may have an incomplete seal, risking a breach in sterility that could lead to infections if used improperly.
Check for the item number 682-001, serial numbers starting with 22236489633, or UDI/DI codes M7526820011 (case) and M7526820010 (kit).
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-0537-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0537-2023 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.
