Stradis Healthcare recalls HENRY SCHEIN Major Extremity Pack (Item 570-2783) due to potential sterility breaches from incomplete bag sealing. Affected units include specific serial numbers and UDI codes.
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 Major Extremity Packs (Item No. 570-2783) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the surgical kit, risking infection during medical procedures.
The outer bag may not seal completely during manufacturing, creating a path for contaminants to enter the sterile surgical kit. This could lead to infections if the kit is used during medical procedures without proper sterilization.
Healthcare professionals using the HENRY SCHEIN Major Extremity Pack for surgical procedures are most at risk if the kit is used without proper sterility.
Check for the product name 'HENRY SCHEIN Major Extremity Pack', item number 570-2783, and specific serial numbers or UDI codes listed in the recall notice.
Identify the product by checking the item number 570-2783 and serial numbers listed in the recall notice.
The recall states that the product may have incomplete bag sealing, which could breach sterility. It is not recommended for use until the recall remedy is followed.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance on next steps.
Look for the item number 570-2783 and specific serial numbers or UDI codes listed in the recall notice.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0516-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0516-2023 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.
