Stradis Healthcare recalls angioplasty kits with potential sterility breaches due to incomplete sealing. Affected kits may not be sterile, risking infection during medical procedures.
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 angioplasty kits that may have incomplete sealing of the outer bag, risking a breach in sterility. This could lead to infections during medical procedures if the kit is used without proper sterility.
The outer bag may not seal properly during manufacturing, creating a path for contamination. If the kit is used without proper sterility, it could lead to infections during medical procedures.
Healthcare professionals using Stradis Healthcare angioplasty kits with specific serial numbers. Patients undergoing procedures with these kits are at risk of infection if the kit is not sterile.
Check for the serial numbers 22237490509 or the UDI/DI codes M75268219371 (case) and M75268219370 (kit). These kits were sold with specific model numbers and serial numbers.
Look for the serial number 22237490509 or the UDI/DI codes M75268219371 (case) and M75268219370 (kit) on the product.
The outer bag may not seal properly during manufacturing, potentially breaching sterility and risking infections during medical procedures.
Check for the serial number 22237490509 or the UDI/DI codes M75268219371 (case) and M75268219370 (kit) on the product.
The recall record 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-0544-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0544-2023 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.
