Stradis Healthcare recalls breast surgical trays with possible sterility breaches due to incomplete bag sealing. Affected units have specific serial numbers and UDI codes. Consumers should contact the manufacturer for details.
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 breast surgical 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 are incompletely sealed during manufacturing. This could allow contamination, potentially leading to infections if the trays are used without proper sterility.
Surgical patients and healthcare providers using Stradis Healthcare breast surgical trays with the specific serial numbers and UDI codes listed. Those at highest risk are individuals undergoing procedures requiring these trays.
Check for the serial number 22242490001 or UDI codes M7526932761 (case) and M7526932760 (kit) on the product packaging.
Look for the serial number 22242490001 or UDI codes M7526932761 (case) and M7526932760 (kit) on the product packaging.
The product is Stradis Healthcare Breast, Item No. 693-276 with serial number 22242490001 or UDI codes M7526932761 (case) and M7526932760 (kit).
Check for the serial number 22242490001 or UDI codes M7526932761 (case) and M7526932760 (kit) on the product packaging.
The recall record does not specify a remedy, so contact Stradis Healthcare directly 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-0555-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0555-2023 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.
