Stradis Healthcare recalls a general surgery tray (Item No. 570-1508) 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 a general surgery tray (Item No. 570-1508) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, risking infection during surgery.
The outer bag may not seal properly during manufacturing, allowing contaminants to enter the sterile kit. This breach could lead to infections during surgical procedures if the kit is used without proper sterility.
Healthcare professionals using this surgery tray for procedures are most at risk. Patients undergoing surgery with this kit could face infection if sterility is compromised.
Check for the item number 570-1508 on the tray. Look for UDI/DI codes: H65857015081 (case) and M75257015080 (kit). Serial numbers start with 22252490204.
Verify the item number, UDI/DI codes, and serial numbers to confirm if your tray is affected.
The recall is for potential sterility breaches, which could lead to infection during surgery. However, the risk is low as the issue is related to manufacturing, not immediate harm.
Check for the item number 570-1508, UDI/DI codes H65857015081 (case) and M75257015080 (kit), and serial numbers starting with 22252490204.
The recall does not specify a remedy, so check the product details to confirm if it's affected. If affected, contact Stradis Healthcare for further instructions.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0506-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0506-2023 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.
