Stradis Healthcare recalls femoral and vascular procedure trays with potential sterility breaches due to incomplete sealing. Affected items have specific serial numbers and UDI codes.
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 femoral and vascular surgical trays that may have incomplete sealing of the outer bag, risking sterility breaches. This could lead to infections if the trays are used without proper sterility.
The trays may have outer bags that are not sealed properly during manufacturing. This could allow contamination, leading to infections if the trays are used without adequate sterility.
Healthcare professionals using the recalled femoral and vascular procedure trays. Patients undergoing surgery with these trays are at risk of infection if sterility is compromised.
Check for the serial numbers 22236491028, UDI/DI codes M7526861421 (case) and M7526861420 (kit) on the product packaging.
Look for serial numbers 22236491028, UDI/DI codes M7526861421 (case) and M7526861420 (kit) on the product packaging.
The outer bag may not be sealed properly, risking sterility breaches that could lead to infections if the trays are used without adequate sterility.
Check for serial number 22236491028, UDI/DI code M7526861421 (case) or M7526861420 (kit) on the product packaging.
The recall record 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-0553-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0553-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
