Stradis Healthcare recalls HENRY SCHEIN Extremity Pack (Item 570-2946) due to potential sterility breaches from incomplete bag sealing. Affected kits may not be sterile, risking infection during surgery.
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 their HENRY SCHEIN Extremity Pack (Item 570-2946) because the outer bag might not seal properly, which could cause the medical kit to lose sterility. This means the kit might not be safe for surgical procedures, increasing infection risk.
The outer bag may not seal completely during manufacturing, creating a breach in the kit's sterility. This could allow contaminants to enter the kit, making it unsafe for surgical use and potentially causing infections.
Healthcare professionals using this medical kit for surgeries or procedures are most at risk. Patients undergoing surgery with this kit could face infection if the sterility is compromised.
Check for the item number 570-2946 on the HENRY SCHEIN Extremity Pack. The UDI/DI (case) is H65857029461 and the UDI/DI (kit) is M75257029460. Serial/Lot Numbers start with 22242490745.
Inspect the outer bag for signs of incomplete sealing, such as leaks or bulges.
Yes, the recall affects medical kits used in surgeries. If the kit is not sterile, it could lead to infections during procedures.
Look for the item number 570-2946 on the HENRY SCHEIN Extremity Pack. The UDI/DI (case) is H65857029461 and the UDI/DI (kit) is M75257029460. Serial/Lot Numbers start with 22242490745.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance on safe handling or disposal.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0526-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0526-2023 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.
