Stradis Healthcare recalls Basic Implant Pack oral surgery trays with potential sterility breaches due to incomplete sealing. Affected units include specific model numbers and serials. Consumers should contact for remedy 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 its Basic Implant Pack oral surgery trays because manufacturing issues may cause the outer bag to be incompletely sealed. This could breach the sterility of the surgical kit, risking infection during procedures.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterile environment needed for surgical kits and increasing infection risk during procedures.
Healthcare professionals using the recalled oral surgery trays for procedures are most at risk. Patients undergoing surgery with these trays could face infection if the sterility is compromised.
Check for the model number 40561BIP on the tray, or serial numbers 22228490663, 22242491516. The product was sold with specific UDI/DI codes and lot numbers listed in the recall notice.
Reach out to Stradis Healthcare for specific instructions on how to handle the recalled product.
The model number is 40561BIP.
The serial numbers are 22228490663, 22242491516.
Check for the model number 40561BIP or the serial numbers 22228490663, 22242491516 on the product.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0488-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0488-2023 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.
