Stradis Healthcare recalls ENT Setup Pack (Item 570-2742) due to potential sterility breaches from incomplete bag sealing. Affected units sold with specific UDI/DI 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 ENT Setup Packs that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if used without proper sterilization.
The outer bag may not seal properly during manufacturing, potentially allowing contamination. If the kit is used without proper sterilization, it could lead to infections during medical procedures.
Healthcare professionals using ENT setup packs for medical procedures. Those handling the specific item numbers listed in the recall are most at risk.
Check for the item number 570-2742 on the ENT Setup Pack. Look for UDI/DI codes H65857027421 (case) and M75257027420 (kit). Serial numbers starting with 22252489778 indicate affected units.
Identify the item number (570-2742), UDI/DI codes (H65857027421 for case, M75257027420 for kit), and serial numbers starting with 22252489778.
The outer bag may not seal properly during manufacturing, potentially leading to sterility breaches if used without proper sterilization.
Check for item number 570-2742, UDI/DI codes H65857027421 (case) and M75257027420 (kit), and serial numbers starting with 22252489778.
The recall does not specify a remedy, so contact Stradis Healthcare for further instructions.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0514-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0514-2023 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.
