Stradis Healthcare recalls sterile oral surgery trays (Item No.003-3880) that may have incomplete bag seals, risking sterility breaches 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 sterile oral surgery trays that may have incomplete bag seals, which could breach sterility and lead to infections during surgery. This affects medical professionals using the product for oral procedures.
The trays may have incomplete bag seals during manufacturing, which could allow contamination. This breach in sterility might lead to infections during surgical procedures if the tray is used without proper sterilization.
Medical professionals using the recalled sterile oral surgery trays for oral procedures. Patients undergoing surgery with these trays are at risk of infection if sterility is compromised.
Look for the product name 'ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray' with UDI/DI code M75200338800 and serial number 22242490999.
Verify the product's UDI/DI code (M75200338800) and serial number (22242490999) to confirm if it's recalled.
The recall is for potential sterility breaches, which could lead to infections during surgery. However, the risk is low as the issue is related to manufacturing conditions, not immediate harm.
Check for the UDI/DI code M75200338800 and serial number 22242490999 on the product label.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0482-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0482-2023 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.