Stradis Healthcare recalls surgical kits with item 40649ECS due to potential bag seal failure causing sterility breaches. Affected kits may not be sterile, risking infection during 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 surgical kits that may have incomplete bag seals, risking contamination 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 the kit's sterility. This could allow contaminants to enter the kit, increasing infection risk during medical procedures.
Healthcare professionals using the surgical kits for procedures. Patients undergoing surgery are at risk if the kits are used without proper sterility.
Check for item number 40649ECS on the kit. Look for UDI/DI codes M75240649ECS1 (case) or M75240649ECS0 (kit), and serial numbers starting with 22270491425.
Look for item number 40649ECS, UDI/DI codes M75240649ECS1 or M75240649ECS0, and serial numbers starting with 22270491425.
The recall is due to potential incomplete sealing of the outer bag during manufacturing, which could breach sterility.
Check the labels for the item number and serial numbers to confirm if it's affected. If it is, stop using it and contact Stradis Healthcare for further instructions.
The recall record does not mention a remedy or fix; affected kits should not be used.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0489-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0489-2023 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.
