Stradis Healthcare recalls Novasure Pack surgery trays with potential sterility breaches due to incomplete bag sealing. Affected items have specific serial numbers and were sold through Henry Schein.
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 Novasure Pack general surgery trays that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if the tray is used without proper sterility.
The outer bag may not seal properly during manufacturing, creating a breach in the sterility of the surgical kit. This could allow contaminants to enter the kit, increasing infection risk during procedures.
Surgical teams and hospitals using the Novasure Pack surgery trays with serial numbers starting with 22230491082. Patients undergoing surgery with these trays are at risk of infection if sterility is compromised.
Check for serial numbers starting with 22230491082 on the tray. The product was sold through Henry Schein under item number 570-1462.
Inspect the outer bag for signs of incomplete sealing, such as gaps or tears.
The recall is for potential sterility breaches, which could increase infection risk during surgery. However, the hazard is not described as causing serious injury in normal use.
Look for serial numbers starting with 22230491082 on the Novasure Pack surgery tray sold through Henry Schein.
The recall does not specify a remedy, so check for sterility issues and 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-0504-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0504-2023 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.
