Stradis Healthcare recalls temp stimulator supplies (Item No. 570-2883) due to potential sterility breaches from incomplete bag sealing. Affected units may cause 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 temp stimulator supplies that may have incomplete bag seals, risking sterility breaches during medical procedures. This could lead to infections if the kits are used without proper sterility.
The outer bags may not seal properly during manufacturing, creating a path for contamination. This breach could compromise the sterility of the medical kits, increasing infection risk during procedures.
Healthcare professionals using the recalled temp stimulator supplies for medical procedures are most at risk. Patients receiving these supplies could face infection if the kits are not sterile.
Check for Item No. 570-2883 on the packaging. The UDI/DI (case) is H65857028831 and UDI/DI (kit) is M75257028831. Serial/Lot Numbers start with 22229489323.
Verify the item number, UDI/DI codes, and serial/lot numbers on the packaging to confirm if it's affected.
The outer bags may not seal properly during manufacturing, potentially breaching sterility and increasing infection risk during medical procedures.
Look for Item No. 570-2883, UDI/DI (case) H65857028831, UDI/DI (kit) M75257028831, and serial/lot numbers starting with 22229489323.
The recall record does not specify a remedy, so contact Stradis Healthcare directly for guidance.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0520-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0520-2023 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.
