Stradis Healthcare recalls Labiaplasty PackItem No.570-3118 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 Labiaplasty PackItem No.570-3118 because the outer bag may not seal properly, risking contamination during medical procedures. This could lead to infections if the sterile kit is used without proper sterility.
The outer bag may not seal completely during manufacturing, which could allow contamination of the sterile kit. If the kit is used without proper sterility, it might cause infections during medical procedures.
Healthcare providers using the Labiaplasty PackItem No.570-3118 for medical procedures are most at risk. Patients receiving the procedure may also be affected if the kit is not sterile.
Check for the product name 'Labiaplasty PackItem No.570-3118' with UDI/DI (case) H65857031181 or (kit) M75257031180. Serial numbers starting with 22234491292 indicate affected units.
Verify the UDI/DI (case) H65857031181 or (kit) M75257031180 and serial numbers starting with 22234491292.
The Labiaplasty PackItem No.570-3118 with UDI/DI (case) H65857031181 or (kit) M75257031180 and serial numbers starting with 22234491292.
The outer bag may not seal completely, risking contamination of the sterile kit during medical procedures.
Check the product details to confirm if it's affected; no specific action is required beyond verification as the remedy is not stated.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0533-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0533-2023 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.
