Stradis Healthcare recalls Endo Pack trays with possible sterility breaches due to incomplete sealing. Affected units have specific serial numbers and item numbers. Consumers should contact for remedy.
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 Endo Pack medical trays that may have incomplete sealing, risking sterility breaches. This could lead to infections if used improperly.
The trays may have outer bags that aren't sealed properly, which can cause the sterility of the medical kit to be compromised. This could lead to infections if the kit is used without proper sterility.
Healthcare professionals and surgical teams using the Endo Pack trays. Those handling the specific serial numbers or item numbers are most at risk.
Check for the item number 682-509, serial numbers starting with 22256490827, or UDI/DI codes M7526825091 and M7526825090 on the product.
Look for the item number 682-509, serial numbers starting with 22256490827, or UDI/DI codes M7526825091 and M7526825090.
The outer bag may not be sealed properly, risking sterility breaches and potential infections.
Check for item number 682-509, serial numbers starting with 22256490827, or UDI/DI codes M7526825091 and M7526825090.
The recall record does not specify a remedy, so 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-0550-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0550-2023 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.
