Stradis Healthcare recalls dental surgical packs with potential sterility breaches due to incomplete sealing. Affected units include specific model numbers and serial lots. Consumers should contact the company for details.
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 dental surgical packs that may have incomplete sealing of the outer bag, risking sterility breaches. This could lead to infections if used without proper sterilization.
The outer bag may not seal properly during manufacturing, creating a breach in the sterility of the kit. This could allow contamination if the kit is used without being properly sterilized.
Dental professionals and patients using the recalled Surg Pack dental kits. Those with the specific model numbers and serial lots are most at risk.
Check for the model number 40450SMS, serial/lot numbers 22262490676, or UDI/DI codes M75240450SMS1 (case) and M75240450SMS0 (kit).
Look for the model number 40450SMS, serial/lot numbers 22262490676, or UDI/DI codes M75240450SMS1 (case) and M75240450SMS0 (kit).
The model number is 40450SMS.
The recall does not specify a remedy, so contact Stradis Healthcare directly for instructions.
The recall describes a potential sterility breach, which could lead to infections if not properly sterilized, but no specific serious injury risk is mentioned.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0485-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0485-2023 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.
