Stradis Healthcare recalls medical vein trays with item number 682-330 due to potential sterility breaches from incomplete bag sealing. Affected units have 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 medical vein trays (item 682-330) because the outer packaging may not seal properly, risking contamination during surgery. This could lead to infections if the sterile kit is used without proper sterility.
The trays' outer bags may not seal completely during manufacturing, creating a path for contaminants to enter the sterile kit. This could lead to infections if the kit is used without proper sterility checks.
Healthcare providers using these medical vein trays for procedures are most at risk. Patients undergoing surgery with the recalled trays could face infection if the sterile kit is compromised.
Check for item number 682-330 on the tray. Affected units have UDI/DI (case) M7526823301 or (kit) M7526823300, and serial numbers starting with 22238490518.
Look for item number 682-330, UDI/DI codes M7526823301 (case) or M7526823300 (kit), and serial numbers starting with 22238490518.
The trays may have incomplete bag sealing, which could breach sterility and lead to infections if used without proper sterility checks.
Check for item number 682-330, UDI/DI codes M7526823301 (case) or M7526823300 (kit), and serial numbers starting with 22238490518.
The recall does not specify a remedy, so contact Stradis Healthcare 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-0547-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0547-2023 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.
