Stradis Healthcare recalls HENRY SCHEIN Insertion Tray (Item No.570-3131) due to potential sterility breaches from incomplete bag sealing. Affected units have 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 Insertion Tray (Item No.570-3131) because manufacturing issues could cause the outer bag to be incompletely sealed. This might breach the sterility of the surgical kit, risking infection during medical procedures.
The tray's outer bag may not seal properly during manufacturing, creating a path for contaminants to enter the sterile kit. This could lead to infections if the kit is used in medical procedures without being properly sterilized.
Healthcare professionals using the HENRY SCHEIN Insertion Tray for medical procedures are most at risk. Patients undergoing surgery could face infection if the kit is used without proper sterility.
Check for the product name 'HENRY SCHEIN Insertion Tray' with item number 570-3131. Affected units have specific serial numbers (22257490596) and UDI codes (H65857031311 for case, M75257031310 for kit).
Identify the item number (570-3131), serial number (22257490596), and UDI codes (H65857031311 or M75257031310) to confirm if your unit is affected.
The recall is due to potential manufacturing issues that could cause the outer bag to be incompletely sealed, risking a breach in the sterility of the surgical kit.
The official recall notice does not specify a remedy or action for affected units. Check product details to confirm if your unit is affected.
Look for the item number 570-3131, serial number 22257490596, and UDI codes H65857031311 (case) or M75257031310 (kit).
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0534-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0534-2023 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.
