Stradis Healthcare recalls vein trays with item number 570-2738 due to potential sterility breaches from incomplete bag sealing. Affected units 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 vein trays with item number 570-2738 because manufacturing may cause the outer bag to be incompletely sealed. This could breach the sterility of the medical kit, risking infection during procedures.
The outer bag may not seal properly during manufacturing, creating a path for contaminants to enter the sterile kit. This could lead to infections during medical procedures if the kit is used without proper sterility.
Healthcare professionals using the vein tray for medical procedures are most at risk. Patients receiving procedures with this kit could face infection if sterility is compromised.
Check for item number 570-2738 on the vein tray. The UDI/DI (case) is H65857027381 and UDI/DI (kit) is M75257027380. Serial numbers start with 22257490591.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your vein tray is affected.
The recall is for potential sterility breaches, which could lead to infection during medical procedures. However, the risk is low as the issue is related to manufacturing conditions, not immediate danger.
Check for item number 570-2738, UDI/DI (case) H65857027381, UDI/DI (kit) M75257027380, and serial numbers starting with 22257490591.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0513-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0513-2023 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.