Stradis Healthcare recalls Blue Tail Custom Pack medical trays due to potential sterility breaches from incomplete bag sealing. Affected units have specific serial numbers and item 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 Blue Tail Custom Pack medical trays that may have incomplete bag sealing, risking sterility breaches. This could lead to infections if the trays are used without proper sterility.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the medical kits and increasing infection risks during procedures.
Healthcare professionals and medical facilities using the Blue Tail Custom Pack trays with serial numbers starting with 22258490762 are most at risk. Patients receiving procedures using these trays could face infection risks.
Check for the serial number starting with 22258490762 on the Blue Tail Custom Pack trays. The item number is 570-3091, and the UDI/DI codes are H65857030911 (case) and M75257030910 (kit).
Look for the serial number starting with 22258490762 on the Blue Tail Custom Pack trays.
The recall is due to potential incomplete sealing of the outer bag during manufacturing, which could breach the sterility of the medical kits.
Check for the serial number starting with 22258490762 on the Blue Tail Custom Pack trays. The item number is 570-3091, and the UDI/DI codes are H65857030911 (case) and M75257030910 (kit).
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected serial numbers.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0531-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0531-2023 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.