Stradis Healthcare recalls GYN Pack (Item No.570-2625) due to potential sterility breaches from incomplete bag sealing. Affected kits may not be sterile, risking infection during medical procedures.
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 GYN Packs (Item No.570-2625) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, increasing infection risk during medical procedures.
The manufacturing process may leave the outer bag of the medical kit incompletely sealed. This could allow contamination, potentially breaching the sterility of the kit and increasing infection risk during medical procedures.
Healthcare providers and medical facilities using the GYN Pack (Item No.570-2625) are likely affected. Those performing surgical procedures with the kit are at higher risk of infection.
Check for the product name 'GYN Pack' with Item No.570-2625. The UDI/DI (case) is H65857026251 and UDI/DI (kit) is M75257026250. Serial/Lot Numbers start with 22230491067.
Identify the product using the UDI/DI (case) H65857026251, UDI/DI (kit) M75257026250, or Serial/Lot Number 22230491067.
The recall is due to potential manufacturing issues that may cause the outer bag to be incompletely sealed, risking sterility breaches in the medical kit.
If the outer bag is incompletely sealed, the kit may not be sterile, increasing the risk of infection during medical procedures.
Look for the product name 'GYN Pack' with Item No.570-2625, UDI/DI (case) H65857026251, UDI/DI (kit) M75257026250, or Serial/Lot Number 22230491067.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0510-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0510-2023 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.
