Alcon recalls certain Custom Pak Surgical Procedure Packs due to difficulty removing adhesive liners, which may render the product unusable. The manufacturer has also observed an increase in adhesive-related skin injuries with these affected lots.
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
Alcon is recalling specific Custom Pak Surgical Procedure Packs because the adhesive liners are difficult to remove, potentially making the products unusable. The manufacturer has also reported more adhesive-related skin injuries with these affected lots.
The adhesive components of the affected drapes have difficulty being removed, which can make the product unusable. Additionally, the manufacturer has observed an increase in adhesive-related skin injuries with these specific lots.
Healthcare professionals using these surgical procedure packs for procedures are most at risk. The affected lots are identified by specific UDI codes and lot numbers listed in the recall.
Check your Custom Pak Surgical Procedure Pack for the UDI codes listed in the recall: H5301ALCON1CPAK10B, H5302ALCON2CPAK20E, and the specific lot numbers provided in the recall.
Look for the UDI codes and lot numbers listed in the recall to determine if your product is affected.
The adhesive components of the affected drapes have difficulty being removed, which can make the product unusable. The manufacturer has also observed an increase in adhesive-related skin injuries with these specific lots.
Check your Custom Pak Surgical Procedure Pack for the UDI codes listed in the recall: H5301ALCON1CPAK10B, H5302ALCON2CPAK20E, and the specific lot numbers provided in the recall.
The recall does not specify a remedy, so you should contact Alcon directly to determine next steps.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0354-2023 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0354-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
