Stradis Healthcare recalls eye spear kits with item numbers 9430 and 9431 due to potential sterility breaches from incomplete bag sealing. Affected kits may not be sterile, risking infection during surgery.
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 eye spear surgical kits that could have incomplete bag seals, risking sterility breaches. This means the kits might not be sterile when used, increasing infection risk during medical procedures.
The kits may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, making the kits not sterile when used in surgery. If the kits aren't sterile, infections could occur during procedures.
Surgical teams and medical facilities using Stradis Healthcare eye spear kits with item numbers 9430 or 9431 are most at risk. Patients undergoing surgery with these kits could face infection if the sterility is compromised.
Check for item numbers 9430 or 9431 on the kit. Kits with serial/lot numbers 22270492023 (for 9430) or 22255491774, 22255491484 (for 9431) are affected.
Look for item numbers 9430 or 9431 and associated serial/lot numbers to confirm if the kit is affected.
The recall is due to potential incomplete sealing of the outer bag during manufacturing, which could breach sterility.
Check the kit labels for item numbers 9430 or 9431 and serial/lot numbers to see if it's affected. If affected, contact Stradis Healthcare for instructions.
The recall addresses sterility risks, not direct injury. Infections could occur if the kit isn't sterile, but the record doesn't mention serious injury risks.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0481-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0481-2023 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.
