FDA Device recall Z-0095-2021

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophtha…

FDA Device
Class II
terminated
Published 2020-10-21

On 2020-10-21 the FDA classified a Class II recall of Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophtha… by Alcon Research, citing 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 are….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0095-2021
Classification	Class II
Status	terminated
Initiated	2020-08-24
Published	2020-10-21
Last updated	2026-09-13 11:55 UTC
Company	Alcon Research
Distribution	US

Product

Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Reason

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.

Identifiers

code_info	Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2… Pak Number followed by the corresponding lot numbers are as follows: 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 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 23951

code_info

Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2…

Pak Number followed by the corresponding lot numbers are as follows: 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 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 23951

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.