Stradis Healthcare recalls Endovenous Pack (Item No. 682-494) 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 Endovenous Packs with item number 682-494 because the outer bag might not seal properly, risking contamination during medical procedures. This could lead to infections if the kit is used without proper sterility.
The outer bag may not seal completely during manufacturing, which could allow contamination of the sterile kit. If the kit is used without proper sterility, it might cause infections during medical procedures.
Healthcare professionals using the Endovenous Pack for medical procedures are most at risk. Patients receiving these procedures may also be affected if the kit is used without sterility.
Check for the item number 682-494 on the Endovenous Pack. Look for UDI codes M7526824941 (case) and M7526824940 (kit), and serial numbers starting with 22234489198.
Verify the item number, UDI codes, and serial numbers on the Endovenous Pack to confirm if it is affected.
The outer bag may not seal completely during manufacturing, which could lead to contamination of the sterile kit during medical procedures.
Check for item number 682-494, UDI codes M7526824941 (case) and M7526824940 (kit), and serial numbers starting with 22234489198.
The recall does not specify a remedy, so contact Stradis Healthcare at www.StradisHealthcare.com 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-0549-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0549-2023 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.
