Alcon Research recalls specific Custom-Pak Surgical Procedure Packs containing PROTEXIS latex micro surgical gloves due to potential holes at cuff folds that could increase infection or cross-patient exposure risk.
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
Alcon Research is recalling certain Custom-Pak Surgical Procedure Packs that include PROTEXIS latex micro surgical gloves. These gloves may develop holes at the folding area around the cuffs, which could increase the risk of infection or cross-patient exposure to body fluids during surgery.
The latex micro surgical gloves packaged within these custom packs may degrade over time, causing holes at the folding area around the cuffs. This could allow body fluids to leak through the glove, increasing the risk of infection or cross-contamination between patients and surgeons.
Ophthalmic surgeons who use these specific Custom-Pak Surgical Procedure Packs are affected. The risk is highest for those using the recalled packs during surgery where gloves are critical for infection control.
Check for the specific pack numbers listed in the recall: Pak Number followed by the corresponding lot numbers (e.g., 0433-72 2359088H). The gloves are used by ophthalmic surgeons in eye surgeries.
Look for the pack number followed by the lot number on the product (e.g., 0433-72 2359088H).
If you have a recalled pack, contact Alcon Research to get a replacement or refund.
No, these gloves are specifically used by ophthalmic surgeons in eye surgeries.
Check the pack number followed by the lot number on the product (e.g., 0433-72 2359088H).
Contact Alcon Research to get a replacement or refund.
We’ve drafted a message you can send Alcon Research to request your refund or repair — edit it as you like.
Subject: Recall Z-0095-2021 — Alcon Research Alcon Research Hello, I own a Alcon Research that is covered by recall Z-0095-2021 from Alcon Research. 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.
