Stradis Healthcare recalls thoracic phleb procedure trays with potential sterility breaches due to incomplete sealing. Affected items have specific serial numbers and UDI codes. Consumers should check their product 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 thoracic phleb procedure trays that may have incomplete sealing of the outer bag, risking sterility breaches. This could lead to infections if the kit is used without proper sterility.
The trays may have outer bags that are not sealed properly during manufacturing. This could allow contamination, potentially leading to infections if the sterile kit is used without proper sterility.
Healthcare professionals using the thoracic phleb procedure trays with the specific serial numbers and UDI codes listed. Patients receiving procedures using these trays are at risk of infection if sterility is compromised.
Check for the serial numbers 22237491041 and UDI codes M7268212281 (case) or M7268212280 (kit) on the product packaging.
Look for the serial numbers 22237491041 and UDI codes M7268212281 (case) or M7268212280 (kit) on the product packaging.
The product is Stradis Healthcare Thoracic Phleb, Item No. 682-1228 with serial numbers 22237491041 and UDI codes M7268212281 (case) or M7268212280 (kit).
Check for the serial number 22237491041 and UDI codes M7268212281 (case) or M7268212280 (kit) on the product packaging.
The recall record does not specify a remedy, so check with 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-0538-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0538-2023 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.
