Stradis Healthcare recalls medical procedure trays with possible sterility breaches due to incomplete bag sealing. Affected items include specific model numbers sold through Henry Schein Vein Clinics.
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 medical procedure trays that may have incomplete bag sealing, risking sterility breaches. This could lead to infections if the kits are used without proper sterility.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, potentially leading to infections if the kits are used without adequate sterility.
Healthcare providers using the specific medical trays sold through Henry Schein Vein Clinics are most at risk. Patients using these kits during procedures may face infection risks if sterility is compromised.
Check for the model number 570-1426 on the product. The UDI/DI (case) is H65857014261 and the UDI/DI (kit) is M75257014260. These items were sold through Henry Schein Vein Clinics.
Identify the model number 570-1426 and UDI/DI codes to confirm if your item is affected.
The recall indicates a potential sterility breach risk, but the record does not specify if this has caused injuries or serious harm.
Check for the model number 570-1426, UDI/DI (case) H65857014261, or UDI/DI (kit) M75257014260 on the product.
The recall record does not specify a remedy, so no action is required beyond checking if your item matches the affected details.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0503-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0503-2023 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.
