Windstone Medical recalls sterile ocular packs AMS12947 STERILEEO due to potential sterility issues in surgical kits. Affected lots 192389 and 194805 may not be sterile, risking infection during procedures.
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Windstone Medical is recalling sterile ocular packs that could be contaminated, posing infection risks during surgery. This affects specific lots sold to hospitals and clinics.
The surgical kits may not be sterile due to issues with the saline packaging. This could lead to infections if used during medical procedures.
Hospitals and clinics using the affected lots (192389 and 194805) are most at risk. Patients undergoing surgery with these packs could face infection.
Check for the model AMS12947 STERILEEO with lot numbers 192389 or 194805. The product is sold under Windstone Medical Packaging, Inc.
Look for lot numbers 192389 or 194805 on the packaging.
The recall indicates potential sterility issues, so it is not safe for surgical use without verification.
The official notice does not specify a remedy, so hospitals should contact Windstone Medical for guidance.
Check for lot numbers 192389 or 194805 on the AMS12947 STERILEEO packaging.
We’ve drafted a message you can send Windstone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1081-2024 — Windstone Medical Windstone Medical Hello, I own a Windstone Medical that is covered by recall Z-1081-2024 from Windstone Medical. 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.
