Stradis Healthcare recalls HENRY SCHEIN Basic Extended Pack (Item No. 570-2890) due to potential sterility breaches from incomplete bag sealing. Affected units have specific UDI/DI and serial numbers.
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 HENRY SCHEIN Basic Extended Pack surgical kits because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, risking infection during medical procedures.
The manufacturing process may leave the outer bag of the surgical kit incompletely sealed. This could allow contamination, breaking the sterility of the kit and increasing infection risk during medical procedures.
Healthcare professionals using the HENRY SCHEIN Basic Extended Pack surgical kits are most at risk. Patients receiving procedures with these kits could face infection if sterility is compromised.
Check for the product name 'HENRY SCHEIN Basic Extended Pack' with Item No. 570-2890. Look for UDI/DI (case) H65857028901 or UDI/DI (kit) M75257028900, and serial numbers starting with 22262492001.
Identify the product by checking the UDI/DI (case) H65857028901, UDI/DI (kit) M75257028900, and serial numbers starting with 22262492001.
The recall is due to potential manufacturing issues that may cause the outer bag to be incompletely sealed, risking sterility breaches in the surgical kit.
The official recall notice does not specify a remedy or action for affected units.
Check for the product name 'HENRY SCHEIN Basic Extended Pack' with Item No. 570-2890, UDI/DI (case) H65857028901, UDI/DI (kit) M75257028900, and serial numbers starting with 22262492001.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0521-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0521-2023 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.
