Alcon recalls Infinity FMS Pak devices with potential plastic debris from over-tightening, causing patient injury during procedures. Check product codes to see if affected.
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Alcon is recalling Infinity FMS Pak devices that may cause patient injury if over-tightened with the included plastic wrench, leading to plastic debris during medical procedures. This risk affects specific product models sold in the U.S. and requires immediate attention to prevent harm.
Over-tightening the device with the included plastic wrench can cause plastic debris to break off, which may then be introduced into the patient during medical procedures. This debris could lead to injury or complications if not properly managed.
Medical professionals using the Infinity FMS Pak devices for procedures are most at risk, particularly those who have purchased the recalled models with the specific product codes listed in the recall notice.
Check the product codes listed in the recall notice, such as Catalog No. 8065741085 or Product Code 100003158. The device is sold under the brand Alcon for medical procedures.
Review the product codes listed in the recall notice to confirm if your device is affected.
Ensure the device is tightened correctly without over-tightening to avoid plastic debris.
Over-tightening the device with the included plastic wrench can cause plastic debris to break off, potentially leading to patient injury during procedures.
Check the product codes listed in the recall notice, such as Catalog No. 8065741085 or Product Code 100003158.
No, but you should check if your device is affected and use proper technique to avoid over-tightening.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2408-2023 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2408-2023 from Alcon. 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.
