Reported Oct 21, 2020 · Terminated

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product…

Alcon Research, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research, LLC · 9965 Buffalo Speedway · Houston, TX · 77054-1309

Is this the product you have?

  • Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex
  • Micro Surgical Gloves - Product Usageused by ophthalmic surgeons in a variety of ophthalmic surgeries
Lot codes and dates
  • Pak Number followed by the corresponding
  • lot numbers are as follows

    1,574 of 1,574 codes

    • 0433-72
    • 2359088H
    • 0433-72
    • 2362546H
    • 10008-15
    • 2364745H
    • 10391-04
    • 2383902H
    • 10391-04
    • 2388582H
    • 10391-04
    • 2397523H
    • 10477-17
    • 2346459H
    • 10477-18
    • 2383904H
    • 1087-63
    • 2353407H
    • 1087-64
    • 2395495H
    • 11016-11
    • 2350017H
    • 11311-07
    • 2403959H
    • 11311-07
    • 2406031H
    • 11345-08
    • 2363773H
    • 11345-08
    • 2363774H
    • 11345-08
    • 2363775H
    • 11437-03
    • 2362137H
    • 11437-03
    • 2379506H
    • 11437-03
    • 2385658H
    • 11437-03
    • 2394132H
    • 11458-17
    • 2370067H
    • 11458-17
    • 2375171H
    • 11458-17
    • 2390120H
    • 11458-17
    • 2393525H
    • 11458-17
    • 2400520H
    • 11786-01
    • 2347153H
    • 11786-01
    • 2380332H
    • 1179-43
    • 2379382H
    • 1179-43
    • 2384124H
    • 1179-43
    • 2384125H
Amount recalled
16,971 Paks

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 17, 2021 · Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.