Stradis Healthcare recalls dental custom pack item 41137TDS due to potential sterility breaches from incomplete bag sealing. Affected units have specific UDI/DI and serial 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 dental custom packs that may have incomplete bag sealing, risking sterility breaches. This could lead to infections if used without proper sterilization.
The outer bag may not seal completely during manufacturing, creating a breach in the sterility of the dental kit. This could allow contamination if the kit is used without proper sterilization.
Dentists and dental clinics using the recalled dental custom packs. Patients at risk if the packs are used without proper sterilization.
Check for item number 41137TDS on the pack. Look for UDI/DI codes M75241137TDS1 (case) and M75241137TDS0 (kit), and serial numbers starting with 22230489097.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your pack is affected.
The item number is 41137TDS.
UDI/DI (case) M75241137TDS1 and UDI/DI (kit) M75241137TDS0.
Serial numbers starting with 22230489097.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0495-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0495-2023 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.
