Windstone Medical recalls sterile ocular packs AMS1294:192436, 192774, 196582 due to potential contamination in surgical kits. Affected users should contact for details.
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Windstone Medical is recalling certain sterile ocular packs because the saline solution inside may not be sterile. This could lead to infections during surgery if the pack is used without proper sterility checks.
The saline solution included in the surgical kits may not be sterile, which could lead to infections if the pack is used during surgery. This risk exists because the sterility assurance process for the saline is not guaranteed.
Healthcare professionals using the recalled ocular packs for surgical procedures are most at risk. Patients receiving these packs during surgery could be affected if the saline is contaminated.
Check for the model number AMS12947A STERILEEO on the packaging. The lot numbers 192436, 192774, and 196582 are associated with this recall.
Identify the model number and lot numbers to confirm if your pack is recalled.
The recall is for potential contamination risk, but the hazard level is low as the sterility issue does not cause immediate injury.
Look for the model number AMS12947A STERILEEO and lot numbers 192436, 192774, or 196582 on the packaging.
The recall does not specify a remedy, so contact Windstone Medical for further instructions.
We’ve drafted a message you can send Windstone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1080-2024 — Windstone Medical Windstone Medical Hello, I own a Windstone Medical that is covered by recall Z-1080-2024 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.
