Stradis Healthcare recalls breast packs with item #570-2397 due to potential sterility breaches from incomplete bag sealing. Affected kits may not be sterile, risking infection during surgery.
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 packs with item number 570-2397 because the outer bags might not seal properly, which could cause the medical kits to lose sterility. This means the kits might not be safe for surgical procedures and could lead to infections if used.
The outer bags may not seal completely during manufacturing, creating a path for contamination. If the kit is not sterile, it could introduce bacteria during surgery, increasing infection risk.
Healthcare professionals using breast packs for surgical procedures are most at risk. Patients undergoing surgery with these kits could face infection if the sterility is compromised.
Check for item number 570-2397 on the breast pack. The UDI/DI (case) is H65857023971 and UDI/DI (kit) is M75257023970. Serial/Lot Numbers start with 22235489451.
Verify if the breast pack has the item number 570-2397 and matching UDI/DI or serial numbers listed in the recall.
The recall is for potential sterility breaches, which could lead to infection during surgery. However, the risk is low as the issue is manufacturing-related and not active in use.
Look for item number 570-2397 on the breast pack. The UDI/DI (case) is H65857023971 and UDI/DI (kit) is M75257023970. Serial/Lot Numbers start with 22235489451.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance on handling the product.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0509-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0509-2023 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.
