{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183365", "product_res_number": "Z-0095-2021", "event_date_initiated": "2020-08-24", "event_date_created": "2020-10-09", "recall_status": "Terminated", "event_date_terminated": "2021-11-17", "res_event_number": "86315", "product_code": "LRO", "k_numbers": [ "K880961" ], "product_description": "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.", "code_info": "Pak Number followed by the corresponding lot numbers are as follows:   0433-72\t2359088H 0433-72\t2362546H 10008-15\t2364745H 10391-04\t2383902H 10391-04\t2388582H 10391-04\t2397523H 10477-17\t2346459H 10477-18\t2383904H 1087-63\t2353407H 1087-64\t2395495H 11016-11\t2350017H 11311-07\t2403959H 11311-07\t2406031H 11345-08\t2363773H 11345-08\t2363774H 11345-08\t2363775H 11437-03\t2362137H 11437-03\t2379506H 11437-03\t2385658H 11437-03\t2394132H 11458-17\t2370067H 11458-17\t2375171H 11458-17\t2390120H 11458-17\t2393525H 11458-17\t2400520H 11786-01\t2347153H 11786-01\t2380332H 1179-43\t2379382H 1179-43\t2384124H 1179-43\t2384125H 1179-43\t2388444H 1179-43\t2388445H 11876-18\t2362142H 11876-18\t2369176H 11876-18\t2379510H 1231-57\t2365132H 1231-57\t2369489H 1231-57\t2372302H 1231-57\t2383379H 1231-57\t2391174H 1231-57\t2393089H 1231-57\t2399904H 1231-57\t2401798H 1231-57\t2403559H 12732-05\t2394138H 12736-09\t2365968H 12736-09\t2375271H 12736-09\t2390575H 12736-09\t2392097H 12736-09\t2395160H 12878-13\t2384211H 12878-13\t2385672H 12896-09\t2358037H 12896-09\t2376070H 12896-09\t2385542H 12896-09\t2387051H 12896-09\t2394141H 12896-09\t2395582H 13152-08\t2384214H 13193-11\t2372672H 13193-11\t2394902H  13194-12\t2346890H 13194-13\t2363370H 13194-13\t2369833H 13194-13\t2377937H 13194-13\t2390027H 13194-13\t2391920H 13194-13\t2392322H 13194-13\t2396531H 13194-13\t2400270H 13194-13\t2402421H 13235-16\t2324761H 13391-09\t2315328H 13391-09\t2343461H 13391-09\t2350133H 13391-09\t2357090H 13391-10\t2370048H 13391-10\t2378299H 13391-10\t2380086H 13391-10\t2390108H 13391-10\t2393512H 13391-10\t2396778H 13391-10\t2399535H 13477-10\t2357278H 13477-10\t2361677H 13477-10\t2363897H 13477-10\t2365971H 13477-10\t2370199H 13477-10\t2375273H 13477-10\t2380877H 13477-10\t2390175H 13477-10\t2392100H 13477-10\t2394534H 13667-08\t2346266H 13667-09\t2361271H 13667-09\t2365630H 13667-09\t2378038H 13667-09\t2383643H 13667-09\t2396582H 13667-09\t2400368H 13698-13\t2384221H 13698-13\t2387057H 13698-13\t2394149H 13699-16\t2362174H 13699-16\t2389133H 13699-16\t2392378H 13699-16\t2399300H 13700-16\t2366535H 13700-16\t2388008H 13700-16\t2396979H 13702-18\t2362175H 13702-18\t2379482H 13702-18\t2389134H 13702-18\t2392379H 13702-18\t2395588H 13777-12\t2369193H 13777-12\t2389136H 13777-12\t2392382H 13777-12\t2396981H 13909-02\t2362177H 13909-02\t2385684H 14049-09\t2358048H 14049-09\t2369194H 14049-09\t2379487H 14049-09\t2387060H  14049-09\t2389139H 14049-09\t2392385H 14049-09\t2395593H 14049-09\t2399305H 14228-06\t2376082H 14295-01\t2322279H 14295-02\t2400274H 14319-06\t2373436H 14319-06\t2385550H 14319-06\t2389142H 14319-06\t2392390H 14319-06\t2395598H 14329-04\t2385268H 14329-04\t2401377H 14424-10\t2356092H 14424-10\t2357456H 14424-11\t2361756H 14424-11\t2363987H 14424-11\t2370331H 14424-11\t2373012H 14424-11\t2380958H 14424-11\t2390236H 14424-11\t2392161H 14424-11\t2395249H 14424-11\t2400750H 14443-09\t2365548H 14443-09\t2377947H 14443-09\t2383076H 14443-09\t2393359H 14443-09\t2396539H 14443-09\t2400277H 14443-09\t2402002H 14489-07\t2389143H 14489-07\t2392392H 14489-07\t2396983H 14569-06\t2349153H 14569-06\t2372002H 14677-06\t2359127H 14677-06\t2363381H 14677-06\t2377953H 14677-06\t2379923H 14677-06\t2387761H 14677-06\t2387850H 14677-06\t2388182H 14692-08\t2358055H 14692-08\t2358305H 14692-08\t2369208H 14692-08\t2376088H 14713-04\t2353346H 14713-04\t2355860H 14713-04\t2365788H 14713-04\t2367878H 14713-04\t2373226H 14713-04\t2374926H 14713-04\t2392883H 14713-04\t2396684H 14713-04\t2398537H 14716-01\t2350064H 14743-03\t2343547H 14743-03\t2357287H 14743-03\t2365978H 14743-03\t2367995H 14743-03\t2370207H 14743-03\t2378387H  14743-03\t2383217H 14743-03\t2390180H 14743-03\t2392104H 14743-03\t2398731H 14743-03\t2400645H 14743-03\t2402263H 14764-06\t2319637H 14764-06\t2371523H 14856-06\t2373437H 14856-06\t2379460H 14856-06\t2385698H 14936-03\t2376092H 15134-06\t2348533H 15134-06\t2392318H 15134-06\t2392319H 15246-02\t2380571H 15286-07\t2319652H 15286-08\t2367115H 15482-17\t2383274H 15482-17\t2387319H 15482-17\t2392341H 15503-05\t2369219H 15503-05\t2376097H 15503-05\t2376098H 15503-05\t2385561H 15503-05\t2395606H 15503-05\t2396989H 15511-02\t2366558H 15641-05\t2362192H 15641-05\t2369230H 15641-05\t2379471H 15641-05\t2385705H 15764-03\t2379473H 15784-04\t2384237H 15784-04\t2399319H 15854-02\t2384239H 15854-02\t2385714H 16003-09\t2399521H 16003-09\t2399522H 16019-07\t2395706H 16088-02\t2317774H 16088-02\t2319671H 16088-02\t2349206H 16108-01\t2389157H 16172-07\t2346663H 16172-07\t2348606H 16172-07\t2399575H 16200-11\t2358965H 16200-11\t2365309H 16243-08\t2342892H 16243-10\t2365170H 16243-10\t2369524H 16243-10\t2387753H 16243-10\t2387835H 16243-10\t2388113H 16243-10\t2397925H 16245-02\t2374009H 16245-02\t2395487H 16245-02\t2399399H 16281-01\t2376112H 16281-01\t2388033H 1635-64\t2357924H 1635-64\t2366482H 1635-64\t2376006H  1635-64\t2385616H 1635-64\t2389089H 1635-64\t2392286H 1635-64\t2396942H 16387-01\t2362199H 16387-01\t2387072H 16387-01\t2401282H 16499-02\t2376116H 16499-02\t2379427H 1667-77\t2389090H 1667-77\t2392287H 16809-05\t2373466H 16895-03\t2384260H 16895-03\t2385740H 16936-06\t2357518H 16936-06\t2390255H 16936-06\t2392175H 16936-06\t2394577H 16936-06\t2396900H 16936-06\t2400787H 16937-04\t2359598H 16937-04\t2370369H 16937-04\t2390256H 16937-04\t2394097H 16937-04\t2396901H 16937-04\t2398846H 16983-03\t2319720H 17026-02\t2358974H 17026-03\t2367655H 17032-03\t2385743H 17064-05\t2363924H 17064-05\t2370233H 17064-05\t2372968H 17064-05\t2390583H 17064-05\t2393625H 17119-02\t2373471H 17119-02\t2385595H 17119-02\t2395634H 17120-02\t2387082H 17251-02\t2340478H 17251-02\t2340479H 17251-02\t2342763H 17251-02\t2350210H 17251-02\t2370236H 17251-02\t2372972H 17251-02\t2375307H 17251-02\t2378401H 17251-02\t2380896H 17251-02\t2391615H 17251-02\t2392115H 17251-02\t2394544H 17251-02\t2396842H 17251-02\t2398750H 17251-02\t2398751H 17251-02\t2402274H 17251-02\t2403091H 17251-02\t2403092H 17272-02\t2373475H 17272-02\t2385602H 17273-04\t2354509H 17273-04\t2373476H 17273-04\t2384266H 17273-04\t2387083H 17273-04\t2389179H  17273-04\t2392433H 17294-07\t2348727H 17294-07\t2348728H 17294-07\t2361796H 17294-07\t2364025H 17294-07\t2370383H 17294-07\t2375431H 17294-07\t2383296H 17294-07\t2390269H 17294-07\t2392190H 17294-07\t2395274H 17294-07\t2398853H 17294-07\t2400798H 17294-07\t2401425H 17346-06\t2358885H 17346-06\t2360847H 17346-07\t2365202H 17346-07\t2372369H 17346-07\t2374389H 17346-07\t2378596H 17346-07\t2391209H 17346-07\t2393127H 17346-07\t2396395H 17346-07\t2397952H 17346-07\t2399955H 17346-07\t2403602H 17423-08\t2374391H 17423-08\t2383425H 17423-08\t2393129H 17423-08\t2399959H 17434-03\t2380106H 17434-03\t2390133H 17434-03\t2392447H 17434-03\t2392969H 17464-02\t2357330H 17464-02\t2359548H 17464-02\t2366006H 17464-02\t2368000H 17464-02\t2370239H 17464-02\t2375310H 17464-02\t2380157H 17464-02\t2390196H 17464-02\t2392116H 17464-02\t2394546H 17464-02\t2396844H 17464-02\t2398753H 17464-02\t2400674H 17474-03\t2385752H 17474-03\t2392435H 17550-07\t2347187H 17550-07\t2369553H 17550-07\t2372374H 17550-07\t2374395H 17550-07\t2382029H 17550-07\t2389916H 17550-07\t2392797H 17550-07\t2394706H 17550-07\t2396400H 17550-07\t2399962H 1765-62\t2358235H 1765-62\t2368366H 1765-63\t2399511H 17766-02\t2391138H 17766-02\t2397872H  17766-02\t2399866H 17770-02\t2394179H 17785-04\t2366009H 17785-04\t2378404H 17785-04\t2380902H 17785-04\t2390586H 17785-04\t2395186H 17785-04\t2402275H 17824-03\t2395643H 17887-02\t2355291H 17887-03\t2394394H 17887-03\t2396457H 17887-03\t2398086H 17955-03\t2355126H 17955-04\t2378613H 17955-04\t2382034H 17955-04\t2396404H 17983-03\t2394180H 17983-03\t2395644H 18021-02\t2359682H 18021-02\t2368234H 18021-02\t2371219H 18021-02\t2373764H 18021-02\t2381456H 18021-02\t2382189H 18021-02\t2384707H 18021-02\t2399549H 18021-02\t2401485H 18086-02\t2373060H 18086-02\t2383315H 18086-02\t2390288H 18086-02\t2393739H 18086-02\t2394590H 18125-01\t2376032H 18125-01\t2399277H 18126-01\t2358364H 18126-01\t2385749H 18126-01\t2388051H 18266-03\t2367979H 18266-03\t2378352H 18266-03\t2380841H 18266-03\t2388255H 18266-03\t2400578H 18419-04\t2363084H 18419-05\t2367614H 18419-05\t2369572H 18419-05\t2372399H 18419-06\t2378618H 18419-06\t2388076H 18419-06\t2388124H 18486-01\t2359626H 18486-01\t2370436H 18486-01\t2381022H 18486-01\t2388333H 18486-01\t2390303H 18486-01\t2392214H 18486-01\t2395307H 18486-01\t2396921H 18486-01\t2401090H 18486-01\t2401091H 18486-01\t2401092H 18512-01\t2367047H 18512-01\t2370001H 18512-01\t2382149H  18512-01\t2383109H 18512-01\t2388216H 18512-01\t2389389H 18512-01\t2391424H 18512-01\t2393467H 18512-01\t2395030H 18521-01\t2375472H 18521-01\t2395309H 18536-01\t2380854H 18536-01\t2386119H 18536-02\t2393574H 18536-02\t2401436H 18536-03\t2396805H 18536-03\t2398693H 18536-03\t2400587H 18536-03\t2400588H 18588-01\t2391522H 18588-01\t2392929H 18588-01\t2396743H 18588-01\t2398593H 18609-01\t2394369H 18609-01\t2397986H 1871-69\t2387971H 1933-62\t2320192H 1933-62\t2343517H 1933-62\t2363856H 1933-62\t2370139H 1933-62\t2375234H 1933-62\t2380131H 1933-62\t2388265H 1933-62\t2388402H 1933-62\t2402467H 2035-69\t2349421H 2035-69\t2364050H 2035-70\t2368067H 2074-53\t2376012H 2074-53\t2385621H 2147-63\t2315477H 2147-63\t2363604H 2147-63\t2365699H 2147-63\t2378109H 2147-63\t2390525H 2147-63\t2392005H 2147-63\t2395032H 2147-63\t2395033H 2147-63\t2403922H 2427-54\t2379529H 2428-56\t2349795H 2428-56\t2363608H 2428-56\t2378115H 2428-56\t2380707H 2428-56\t2383708H 2428-56\t2393473H 2428-56\t2398449H 2428-56\t2400452H 2556-71\t2350345H 2683-80\t2357933H 2683-80\t2385627H 2683-80\t2392313H 2683-81\t2394118H 2683-81\t2399265H 2828-67\t2376019H 4976-20\t2370464H 4976-20\t2373074H  4976-20\t2375489H 4976-20\t2378512H 4976-20\t2391711H 4976-21\t2395324H 5742-66\t2379534H 5742-66\t2395553H 5813-53\t2366493H 5813-53\t2384180H 5813-53\t2385632H 6005-11\t2373082H 6005-11\t2375498H 6005-11\t2378520H 6005-11\t2396933H 6005-11\t2398910H 6241-27\t2319818H 6241-27\t2320633H 6241-27\t2343572H 6241-28\t2357375H 6241-28\t2363951H 6241-28\t2366030H 6241-28\t2370281H 6241-28\t2378420H 6241-28\t2380180H 6241-28\t2383253H 6241-28\t2395212H 6241-28\t2398788H 6241-28\t2400716H 6241-28\t2401452H 6241-29\t2402289H 6374-22\t2365265H 6374-22\t2369604H 6374-22\t2372430H 6374-22\t2382065H 6374-22\t2388510H 6374-22\t2388511H 6374-22\t2391235H 6374-22\t2392803H 6374-22\t2398010H 6374-22\t2398011H 6374-22\t2400015H 6374-22\t2400972H 6374-22\t2400973H 6919-65\t2354780H 6919-65\t2354781H 6919-65\t2354782H 6919-65\t2354783H 6919-65\t2361209H 6919-65\t2361210H 6919-65\t2361211H 6919-65\t2363471H 6919-65\t2363472H 6919-65\t2377987H 6919-65\t2379937H 6919-65\t2379938H 6919-65\t2379939H 6919-65\t2383103H 6919-65\t2383104H 6919-65\t2393379H 6919-65\t2393380H 6919-65\t2394931H 6919-65\t2394932H 6919-65\t2398344H 6919-65\t2398345H 6919-65\t2400311H  6919-65\t2400312H 6919-65\t2400313H 6919-65\t2402428H 6932-61\t2343122H 6932-61\t2349004H 6932-61\t2359170H 6932-61\t2363473H 6932-61\t2390479H 6932-61\t2393381H 6932-61\t2396560H 6932-61\t2398346H 6932-61\t2400314H 8206-55\t2385638H 8306-63\t2379538H 8306-63\t2385514H 8306-63\t2387040H 8306-63\t2389100H 8306-63\t2392307H 8306-63\t2395559H 8306-63\t2399276H 8323-20\t2363953H 8323-20\t2363954H 8323-20\t2366033H 8323-20\t2366034H 8323-20\t2375347H 8323-20\t2375348H 8323-20\t2388465H 8323-20\t2388466H 8323-20\t2388467H 8323-20\t2393661H 8323-20\t2396868H 8323-20\t2396869H 8323-20\t2398790H 8323-20\t2400720H 8323-20\t2400721H 8371-60\t2362116H 8371-60\t2376033H 8371-60\t2384186H 8371-60\t2387985H 8371-60\t2395560H 8604-59\t2360915H 8604-59\t2369616H 8604-59\t2377698H 8604-59\t2380424H 8604-59\t2391241H 8604-59\t2393179H 8604-59\t2394377H 8604-59\t2398022H 8604-59\t2398023H 8604-59\t2400027H 8639-61\t2400870H 8653-58\t2362119H 8653-58\t2373403H 8653-58\t2385643H 8653-58\t2389101H 8653-58\t2392308H 8653-58\t2395562H 8886-24\t2319910H 8886-24\t2361849H 8886-24\t2369092H 8886-24\t2390333H 8886-24\t2393787H 8886-24\t2402353H 9181-61\t2385522H  9181-61\t2395563H 9235-66\t2363957H 9235-66\t2370285H 9235-66\t2375350H 9235-66\t2380936H 9235-66\t2390598H 9235-66\t2392134H 9235-66\t2394556H 9235-66\t2396871H 9235-66\t2398793H 9235-66\t2400724H NVX-10008-14\tJZ5030128 NVX-10008-14\tJZ5030129 NVX-10008-15\tJZ5031475 NVX-10008-15\tJZ5031478 NVX-10008-15\tJZ5031474 NVX-10008-15\tJZ5031477 NVX-10008-15\tJZ5031479 NVX-10008-15\tJZ5031480 NVX-10008-15\tJZ5031476 NVX-10391-04\tJZ5040959 NVX-10477-18\tJZ5042939 NVX-10477-18\tJZ5037021 NVX-10477-18\tJZ5036163 NVX-10477-18\tJZ5036161 NVX-11016-11\tJZ5040495 NVX-11016-11\tJZ5039057 NVX-11016-11\tJZ5030204 NVX-11017-09 JZ5040497 NVX-11017-09 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  NVX-16200-11\tJZ5038118 NVX-16382-04\tJZ5042875 NVX-16382-04\tJZ5042873 NVX-16382-04\tJZ5040249 NVX-16382-04\tJZ5040246 NVX-16382-04\tJZ5040244 NVX-16382-04\tJZ5040251 NVX-16382-04\tJZ5040242 NVX-16382-04\tJZ5039406 NVX-16382-04\tJZ5039102 NVX-16382-04\tJZ5019104 NVX-1765-62\tJZ5029973 NVX-1765-62\tJZ5029969 NVX-1765-62\tJZ5029971 NVX-1765-62\tJZ5029967 NVX-1765-62\tJZ5029965 NVX-1765-63\tJZ5040980 NVX-1765-63\tJZ5040974 NVX-1765-63\tJZ5040972 NVX-1765-63\tJZ5040976 NVX-1765-63\tJZ5040978 Q38631C\t2387535H", "firm_fei_number": "1000117501", "recalling_firm": "Alcon Research, LLC", "address_1": "9965 Buffalo Speedway", "city": "Houston", "state": "TX", "postal_code": "77054-1309", "additional_info_contact": "713-668-9100", "reason_for_recall": "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.", "root_cause_description": "Nonconforming Material/Component", "action": "Alcon sent their customers an Urgent Medical Device Advisory Letter via Fed-Ex overnight mail beginning on August 24, 2020. The letter notifies customers that Alcon has been informed by Cardinal Health that they have initiated a voluntary recall for specific production lots of Cardinal Health Protexis Latex Micro Surgical Gloves. Customers were informed of the following: records show their facility received Alcon Custom Pak(s) with the affected surgical gloves; the gloves may have a degradation defect which could lead to holes and donning tears around the cuff of the gloves; and that this may present a potential risk of infection or cross patient-clinician exposure to body fluids. Customers were informed that Cardinal Health has received complaints regarding this issue, but that neither Cardinal or Alcon have received any reports of injury or harm. Customers are requested to review storage and usage locations to confirm whether they have any affected, listed in an attachment to the notification letter, in stock. Customers were warned that they may receive additional affected product, packaged and shipped before the recall was initiated. Customers were instructed that upon opening affected Paks, gloves should be removed, segregated and disposed of to prevent their use. Customers are requested to forward the notice to all departments and organizations affected, and fill out and return the Response Form via Fax or email to Alcon at Fax: 817-302-4337 or Email: Market.Actions@a lcon.com even if no product is remaining in stock. Customers were informed that their accounts will be credited to compensate for unused gloves, and that other components in the Alcon Custom Paks are unaffected and may be used. Customers with questions should contact customer service at 1 800 862 5266, or contact their Alcon Sales Representative.", "product_quantity": "16,971 Paks", "distribution_pattern": "U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MN, MO, NE, NJ, NV, NY, OK, PA, TN, TX, UT, WA, WV.", "openfda": { "k_number": [ "K881083", "K903336", "K971062", "K941846", "K925467", "K931758", "K962826", "K932652", "K950295", "K874760", "K873973", "K902888", "K910365", "K924468", "K854095", "K964921", "K931820", "K902887", "K953083", "K871873", "K882684", "K951149", "K890729", "K030721", "K936117", "K041080", "K854292", "K945831", "K902293", "K970187", "K935483", "K944044", "K935743", "K890098", "K964011", "K922648", "K931824", "K910368", "K950574", "K871437", "K945160", "K905459", "K961863", "K920292", "K935740", "K914174", "K934428", "K871434", "K933137", "K971061", "K932220", "K926269", "K923600", "K913136", "K932221", "K914935", 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"medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }