Stradis Healthcare recalls Varicosity Basic Pack (Item No. 682-947) due to potential sterility breaches from incomplete bag sealing. Affected units have specific serial numbers and UDI codes.
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 its Varicosity Basic Pack surgical kits because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, risking infection during medical procedures.
The manufacturing process may leave the outer bag of the kit incompletely sealed. This breach could allow contaminants to enter the sterile kit, increasing infection risk during medical procedures.
Healthcare providers using the Varicosity Basic Pack surgical kits are most at risk. Patients undergoing procedures with these kits could face infection if the sterility is compromised.
Check for the item number 682-947 on the kit. Look for UDI/DI codes M7526829471 (case) and M7526829470 (kit). Serial numbers start with 22236491032.
Look for serial numbers starting with 22236491032 on the kit.
Reach out to Stradis Healthcare for further assistance with the recall.
The recall is due to potential manufacturing issues that may cause the outer bag to be incompletely sealed, risking sterility breaches.
Check the serial numbers and contact Stradis Healthcare for guidance on next steps.
Yes, if the sterility is compromised, it could lead to infection during medical procedures.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0552-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0552-2023 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.
