Stradis Healthcare recalls Angio Pack kits with item number 686-199 due to potential sterility breaches from incomplete bag sealing. Affected units 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 Angio Pack surgical kits that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if the kits are used without proper sterility.
The outer bag may not seal properly during manufacturing, creating a breach in sterility. This could allow contaminants to enter the kit, increasing infection risk during surgical procedures.
Healthcare professionals using the Angio Pack kits for medical procedures are most at risk. Patients receiving surgery using these kits could face infection risks.
Check for item number 686-199 on the kit. Look for UDI/DI codes M7526861991 (case) and M7526861990 (kit). Serial numbers starting with 22236491017 indicate affected units.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your Angio Pack kit is affected.
The outer bag may not seal properly during manufacturing, potentially breaching sterility and increasing infection risk during surgery.
Check for item number 686-199, UDI/DI codes M7526861991 (case) and M7526861990 (kit), and serial numbers starting with 22236491017.
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-0554-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0554-2023 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.
