{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "106304", "product_res_number": "Z-0812-2012", "event_date_initiated": "2011-12-14", "event_date_posted": "2012-01-18", "recall_status": "Terminated", "event_date_terminated": "2014-05-22", "res_event_number": "60720", "product_code": "DWF", "k_numbers": [ "K022272", "K842375", "K845045" ], "product_description": "Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. \nModel # 's\nCB66112, CB66114, CB66116, CB66118, CB66120, CB66122, CB66124, CB66128, CB66130, CB66132, CB66134, CB66136, CB66140, CB66236, CB66240, CB67312, CB67314, CB67316, CB67318, CB67320, CB67512, CB67514, CB67516, CB67518, CB67520, CB67522, CB67524, CB67528, CB67530, CB67532, CB67534, CB67536, CB67540, CB67636, CB67640, CB68112, CB68114, CB68116, CB68118, CB68120, CB68122, CB68124, CB68126, CB68128, CB68130, CB68132, CB68134, CB68136, CB68138, CB68140, CB69312, CB69316, CB69320,CB69322, CB69324, CB69328, CB69331, CB69428.\n\nThese cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.", "code_info": "Model # / Lot #\t\t\t\t\t \t\t\t\t\t CB66112\tCB66114\tCB66116\tCB66118\tCB66120\tCB66122  11813252\t11843724\t11827750\t11843725\t11813258\t11584816 11799778\t11827756\t11785647\t11813251\t11799807\t11561410 11785661\t11785648\t11760072\t11799779\t11754233\t11538323 11760079\t11773439\t11749844\t11785671\t11734973\t11502622 11734945\t11710255\t11710254\t11734970\t11710271\t11452595 11691759\t11691748\t11691757\t11572754\t11669004\t11254883 11613172\t11681293\t11681289\t11561406\t11655514\t11182280 11610933\t11669018\t11641156\t11508900\t11641162\t11150759 11599805\t11599798\t11584819\t11493477\t11627324\t11091693 11572780\t11561382\t11561388\t11434967\t11599813\t10919617 11561378\t11538310\t11502627\t11264460\t11528295\t10856277 11538313\t11528250\t11385846\t11182276\t11490554\t10843209 11411017\t11452576\t11276282\t11173236\t11315471\t10820591 11370812\t11373266\t11182290\t11150770\t11278706\t10792650 11361018\t11370804\t11091678\t11137730\t11241600\t10773248 11326455\t11361014\t11137732\t11123865\t11206047\t10751519 11264468\t11326456\t11123882\t11103220\t11193432\t10721043 11241591\t11254866\t11114391\t11091684\t11173268\t10699666 11231073\t11182289\t11080537\t11069185\t11137743\t10691424 11218584\t11150779\t11069195\t11058824\t11103236\t10613562 11193453\t11137720\t11058842\t11050709\t11108109\t10514225 11137754\t11123863\t11041173\t11041174\t11080547\t10503899 11123841\t11114398\t11028717\t11016744\t11069202\t10487793 11080539\t11069197\t10992835\t10960981\t11041175\t10318730 11058851\t11050712\t10980889\t10923636\t10992836\t10278866 11028715\t11041172\t10832387\t10919615\t10970848\t10269102 11016742\t11028716\t10820589\t10856275\t10960982\t 10980899\t11016743\t10806901\t10843148\t10945751\t 10945750\t11007099\t10792648\t10832388\t10919616\t 10923635\t10992834\t10783528\t10820590\t10856276\t 10919613\t10980884\t10773245\t10806902\t10832389\t 10867469\t10970847\t10699672\t10783529\t10792649\t 10843208\t10960980\t10691455\t10773246\t10773247\t 10832386\t10919614\t10602850\t10751518\t10738032\t 10820587\t10878783\t10569665\t10729510\t10729497\t 10783526\t10856274\t10559130\t10699694\t10721042\t 10729534\t10820588\t10552235\t10691463\t10699704\t 10691412\t10806900\t10542908\t10613407\t10691464\t 10683880\t10792647\t10521730\t10593905\t10683908\t 10674111\t10783527\t10514236\t10577104\t10664495\t 10652292\t10773244\t10503880\t10569677\t10631770\t 10631752\t10751517\t10468804\t10552243\t10621341\t 10593945\t10699689\t10460194\t10526627\t10593931\t 10559122\t10691469\t10443541\t10521722\t10552234\t 10542875\t10683896\t10426841\t10494788\t10542905\t 10514256\t10593942\t10383047\t10468812\t10526630\t 10503859\t10584281\t10380517\t10460167\t10514222\t 10479511\t10569692\t10373509\t10443564\t10494795\t 10480197\t10543465\t10297648\t10420852\t10487845\t 10443537\t10521726\t10278862\t10406890\t10468799\t 10297669\t10503873\t10269077\t10403803\t10460198\t 10232697\t10494786\t10261310\t10397632\t10443550\t 10185498\t10479551\t\t10395337\t10340579\t \t10460193\t\t10318738\t10318753\t \t10451347\t\t10297661\t10282386\t \t10443531\t\t10289587\t10269130\t \t10435584\t\t10278840\t10261341\t \t10426824\t\t10215032\t10191687\t \t10318754\t\t10189491\t10186263\t \t10297653\t\t\t\t \t10289595\t\t\t\t \t10278886\t\t\t\t \t10269114\t\t\t\t \t10261340\t\t\t\t \t10189490\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB66124\tCB66128\tCB66130\tCB66132\tCB66134\tCB66136 11827767\t11627333\t11773446\t11799799\t11827744\t11799792 11773419\t11599767\t11749845\t11681291\t11710269\t11760052 11760049\t11326472\t11710245\t11668999\t11681284\t11572757 11734956\t11218598\t11641155\t11641159\t11627296\t11425915 11710265\t11182291\t11627304\t11627300\t11452588\t11276285 11681302\t11173246\t11599769\t11452587\t11370813\t11231093 11669022\t11154396\t11547341\t11338577\t11315466\t11123840 11655492\t11150767\t11538311\t11326447\t11295324\t11058807 11641165\t11058804\t11361023\t11295323\t11241607\t11041178 11627311\t11055669\t11315461\t11254872\t11206081\t10913654 11613167\t11050669\t11264444\t11206086\t11154378\t10856281 11528290\t11028718\t11028719\t11154399\t11150748\t10751522 11349220\t11007101\t10980910\t11150747\t10945753\t10577107 11326462\t10992837\t10923637\t11058847\t10820595\t10569700 11298131\t10945752\t10674167\t11041177\t10631766\t10542971 11241610\t10901167\t10664513\t11028720\t10613551\t10526622 11231080\t10832391\t10631746\t10930780\t10602851\t10521720 11206066\t10820593\t10602783\t10867470\t10577109\t10468760 11182272\t10806904\t10593927\t10856280\t10552240\t10460162 11154406\t10792651\t10584280\t10843149\t10521701\t10420850 11150755\t10783531\t10577075\t10832392\t10318761\t10370321 11137740\t10762628\t10566526\t10820594\t10289594\t10360543 11058849\t10751521\t10503905\t10806905\t10278841\t10318727 11050668\t10674164\t10494797\t10792652\t10269112\t10261331 11041176\t10631765\t10479479\t10783532\t10261334\t10224560 11007100\t10621311\t10397558\t10773250\t10199614\t10175944 10980906\t10593951\t10395345\t10762629\t10176023\t 10960984\t10583515\t10383009\t10613400\t\t 10856278\t10569669\t10380509\t10583513\t\t 10843210\t10559114\t10360542\t10577110\t\t 10832390\t10552204\t10330246\t10569667\t\t 10820592\t10521705\t10339016\t10460147\t\t 10806903\t10503888\t10322855\t10390319\t\t 10783530\t10494753\t10271119\t10370317\t\t 10773249\t10487834\t10175986\t10360551\t\t 10762627\t10479514\t\t10318749\t\t 10729512\t10468767\t\t10297689\t\t 10593914\t10460140\t\t10199613\t\t 10569680\t10443571\t\t\t\t 10559134\t10408590\t\t\t\t 10542901\t10397633\t\t\t\t 10514237\t10395341\t\t\t\t 10503891\t10380514\t\t\t\t 10487802\t10318809\t\t\t\t 10468761\t10318755\t\t\t\t 10460163\t10297693\t\t\t\t 10443563\t10278837\t\t\t\t 10408593\t10191685\t\t\t\t 10395325\t\t\t\t\t 10390317\t\t\t\t\t 10383058\t\t\t\t\t 10318747\t\t\t\t\t 10310127\t\t\t\t\t 10176022\t\t\t\t\t 10168504\t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB66140\tCB66236\tCB66240\tCB67312\tCB67314\tCB67316 11710278\t10856282\t10913655\t11843701\t11799793\t11773402 \t\t10792653\t11773411\t11773405\t11721260 \t11150766\t10674109\t11710239\t11749854\t11655484 \t\t10659949\t11641133\t11627306\t11613156 \t11173267\t\t11627298\t11315477\t11599771 \t\t\t11613144\t11182266\t11572760 \t11193423\t\t11397357\t11114383\t11538319 \t\t\t11315465\t11069200\t11434981 \t11231092\t\t11058812\t11028721\t11278703 \t\t\t11050681\t11016745\t11193478 \t11278705\t\t11007102\t11007103\t11150787 \t\t\t10992838\t10992839\t11091694 \t11411012\t\t10960985\t10980903\t11050688 \t\t\t10878784\t10970849\t11041180 \t11538331\t\t10832393\t10878785\t10992840 \t\t\t10691448\t10856283\t10970850 \t11627328\t\t10613414\t10832394\t10960986 \t\t\t10535617\t10820596\t10878786 \t11681310\t\t10503871\t10792654\t10831678 \t\t\t10487783\t10773252\t10820597 \t10176010\t\t10479477\t10751523\t10820598 \t\t\t10460161\t10738034\t10773253 \t10232698\t\t\t10721063\t10751525 \t\t\t\t10542920\t10751524 \t10243466\t\t\t10526614\t10729536 \t\t\t\t10514238\t10652290 \t10261358\t\t\t10494790\t10593920 \t\t\t\t10487818\t10569675 \t10278867\t\t\t10479491\t10514250 \t\t\t\t10468802\t10487846 \t10318724\t\t\t10460149\t10479485 \t\t\t\t10448672\t10468800 \t10535599\t\t\t10189494\t10460188 \t\t\t\t10189492\t10435591 \t10542877\t\t\t\t10420843 \t\t\t\t\t10403807 \t10569699\t\t\t\t10318697 \t\t\t\t\t10310119 \t10593943\t\t\t\t10289588 \t\t\t\t\t10278865 \t10613560\t\t\t\t10218174 \t\t\t\t\t10215035 \t10621477\t\t\t\t10199619 \t\t\t\t\t \t10631755\t\t\t\t \t\t\t\t\t \t10643153\t\t\t\t \t\t\t\t\t \t10652271\t\t\t\t \t\t\t\t\t \t10721064\t\t\t\t \t\t\t\t\t \t10738033\t\t\t\t \t\t\t\t\t \t10773251\t\t\t\t \t\t\t\t\t \t11749857\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB67318\tCB67320\tCB67512\tCB67514\tCB67516\tCB67518 11799773\t10176018\t11855547\t10297643\t11827753\t11502624 11773388\t\t11813261\t\t11681280\t11154374 11721247\t10525864\t11799808\t10980872\t10980877\t11137718 11655500\t\t11785633\t\t10691420\t10783533 11627302\t10536236\t10613365\t11655464\t10297644\t10743959 11599778\t\t10593901\t\t\t10232496 11502625\t10542894\t\t11710275\t\t10175992 11326452\t\t\t\t\t 11041181\t10613552\t\t\t\t 10992841\t\t\t\t\t 10919618\t11099826\t\t\t\t 10888953\t\t\t\t\t 10820599\t11108114\t\t\t\t 10593939\t\t\t\t\t 10569674\t11114403\t\t\t\t 10542917\t\t\t\t\t 10521697\t11721238\t\t\t\t 10479539\t\t\t\t\t 10289593\t\t\t\t\t 10278876\t\t\t\t\t 10269127\t\t\t\t\t 10261354\t\t\t\t\t 10255194\t\t\t\t\t 10243449\t\t\t\t\t 10218173\t\t\t\t\t 10218172\t\t\t\t\t 10185494\t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB67520\tCB67522\tCB67524\tCB67528\tCB67530\tCB67532 11749837\t11773418\t11799783\t11799806\t11760053\t11584781 11754236\t11543083\t11721261\t11584783\t11627303\t11540968 11669021\t11610941\t11613139\t11561387\t11572752\t11276283 11627308\t11538303\t11599784\t11538306\t11530556\t11241615 11538328\t11373263\t11572763\t11384694\t11370803\t11231095 11373280\t11298122\t11538309\t11338703\t11349214\t11114371 11349227\t11241631\t11438994\t11295305\t11069205\t11050718 11254894\t11193454\t11370814\t11278698\t11016747\t11041183 11206075\t11123870\t11360994\t11241635\t10970851\t11028723 11182292\t11050676\t11264452\t11206071\t10960987\t11016748 11173224\t10843150\t11254878\t11193448\t10945754\t10888954 11150784\t10820601\t11241623\t11173262\t10514230\t10856288 11028722\t10806906\t11241602\t11150788\t10479496\t10820604 11016746\t10751527\t11231069\t11069177\t10468763\t10792656 11007104\t10613585\t11193438\t11058846\t10435587\t10631780 10980905\t10514229\t11137746\t11050660\t10232679\t10621482 10856285\t10503881\t11123835\t10980916\t10189495\t10602845 10820600\t10494770\t11069188\t10856287\t\t10577087 10773254\t10451323\t11041182\t10843151\t\t10558734 10751526\t10318759\t10992842\t10832396\t\t10514257 10683867\t10297687\t10843211\t10820603\t\t10494796 10674107\t10278853\t10820602\t10792655\t\t10487821 10664501\t10269086\t10773255\t10783534\t\t10479549 10621269\t10261336\t10751528\t10773256\t\t10426811 10621268\t10255180\t10535606\t10751529\t\t10420866 10613429\t10215034\t10494779\t10729532\t\t10318698 10542895\t10194016\t10460192\t10699713\t\t10312644 10535612\t\t10330244\t10683914\t\t10289569 10521703\t\t10322857\t10674171\t\t10232684 10460168\t\t10318737\t10664499\t\t10194032 10420870\t\t10289548\t10652265\t\t 10403801\t\t10269093\t10621483\t\t 10395328\t\t10263877\t10593921\t\t 10370324\t\t10215033\t10569691\t\t 10360554\t\t10175994\t10552220\t\t 10354598\t\t10175985\t10521714\t\t 10318729\t\t\t10503897\t\t 10261367\t\t\t10494769\t\t 10232492\t\t\t10460195\t\t \t\t\t10443546\t\t \t\t\t10318688\t\t \t\t\t10318689\t\t \t\t\t10310114\t\t \t\t\t10289597\t\t \t\t\t10269108\t\t \t\t\t10261311\t\t \t\t\t10232712\t\t \t\t\t10176003\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB67534\tCB67536\tCB67540\tCB67636\tCB67640\tCB68112 11691780\t11799776\t11384688\t11584779\t11813262\t11154393 11627325\t11599804\t\t11538291\t11799809\t11137721 11584818\t11315473\t\t11349219\t11785634\t11080525 11572761\t11193472\t\t11298129\t11732169\t10992843 11538318\t11041185\t\t11123878\t10960988\t10751531 11425919\t10820606\t\t11103223\t\t10203287 11338574\t10683900\t\t11080542\t\t 11276288\t10542972\t\t11069189\t\t 11114390\t10494789\t\t11058850\t\t 11069187\t10460144\t\t11041186\t\t 11050717\t10435537\t\t11028724\t\t 11050654\t\t\t10945756\t\t 11041184\t\t\t10843212\t\t 10980901\t\t\t10683865\t\t 11016749\t\t\t10674110\t\t 11007105\t\t\t10569684\t\t 10945755\t\t\t10542973\t\t 10856289\t\t\t10536238\t\t 10843152\t\t\t10514216\t\t 10832397\t\t\t10496084\t\t 10820605\t\t\t\t\t 10773257\t\t\t\t\t 10751530\t\t\t\t\t 10738035\t\t\t\t\t 10691438\t\t\t\t\t 10683882\t\t\t\t\t 10621494\t\t\t\t\t 10552233\t\t\t\t\t 10542876\t\t\t\t\t 10514241\t\t\t\t\t 10503889\t\t\t\t\t 10487832\t\t\t\t\t 10479499\t\t\t\t\t 10435543\t\t\t\t\t 10420860\t\t\t\t\t 10318732\t\t\t\t\t 10261372\t\t\t\t\t 10224561\t\t\t\t\t 10203282\t\t\t\t\t 10176011\t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB68114\tCB68116\tCB68118\tCB68120\tCB68122\tCB68124 11508865\t11813242\t11691746\t11254886\t11773429\t11813248 11484956\t11734964\t11584789\t11080562\t11721235\t11799766 11091656\t11655472\t11528294\t11058813\t11655478\t11721234 11050663\t11502626\t11338711\t11050675\t11627323\t11641138 11041187\t11058828\t11193474\t11007107\t11584800\t11613154 10751532\t11050686\t11058845\t10992844\t11561402\t11584803 10691422\t11041188\t11050699\t10960989\t11254888\t11452597 10664497\t11028725\t11016750\t10621313\t11193446\t11370808 10232687\t10751533\t11007106\t10613412\t11150797\t11058802 \t10683859\t10919619\t10487841\t11091686\t11050667 \t10318690\t10820607\t10443566\t10856290\t11016751 \t10261324\t10613410\t10426820\t10820608\t10970852 \t10243437\t10318694\t10400250\t10792657\t10960990 \t\t10289565\t10397628\t10773258\t10945757 \t\t10175995\t10318693\t10691475\t10820609 \t\t\t10297680\t10683869\t10792658 \t\t\t10278787\t10664494\t10773259 \t\t\t10269115\t10621308\t10569662 \t\t\t\t10613564\t \t\t\t\t10593937\t \t\t\t\t10569695\t \t\t\t\t10542879\t \t\t\t\t10494757\t \t\t\t\t10479537\t \t\t\t\t10287042\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB68126\tCB68128\tCB68130\tCB68132\tCB68134\tCB68136 11827739\t11827760\t11681282\t11827757\t11785639\t11813223 11773407\t11749829\t11484942\t11760046\t11773435\t11641135 11613138\t11773410\t11218603\t11773447\t11710259\t11502597 11540970\t11721254\t11150750\t11754238\t11655466\t11373272 11540971\t11681294\t11075680\t11734949\t11641125\t11326445 11502612\t11613145\t10960991\t11710244\t11411011\t10992845 11206082\t11254859\t10843153\t11669002\t11114370\t10992845 11108136\t11254874\t10820611\t11655473\t11103232\t10992845 11058827\t11231072\t10751535\t11641126\t11028726\t10960993 11050687\t11206077\t10691449\t11528261\t11007110\t10843214 10913656\t11114372\t10487840\t11241589\t10970853\t10843214 10552215\t11058811\t10460171\t11231067\t10843213\t10843214 10503882\t11050674\t10397562\t11123833\t10832399\t10843214 10487839\t11007108\t10390340\t11007109\t10806908\t10820612 10460143\t10856291\t10380510\t10960992\t10751536\t10792659 10269111\t10820610\t10318733\t10901168\t10558730\t10773260 10176024\t10806907\t10176012\t10878787\t10542980\t10751537 \t10751534\t\t10856293\t10514226\t10552239 \t10503895\t\t10832398\t10479478\t10526617 \t10487799\t\t10664505\t10452170\t10521715 \t10479543\t\t10652262\t10435573\t10487833 \t10460133\t\t10631764\t10176013\t10435575 \t10443547\t\t10613578\t\t10420853 \t10395326\t\t10602844\t\t10339017 \t10390320\t\t10577111\t\t10318721 \t10380506\t\t10569697\t\t10278857 \t10318723\t\t10514228\t\t10224558 \t10261342\t\t10487801\t\t10175977 \t10255183\t\t10435535\t\t \t10186264\t\t10420856\t\t \t\t\t10397560\t\t \t\t\t10380515\t\t \t\t\t10330247\t\t \t\t\t10339020\t\t \t\t\t10322860\t\t \t\t\t10310107\t\t \t\t\t10278881\t\t \t\t\t10269080\t\t \t\t\t10261309\t\t \t\t\t10218186\t\t \t\t\t10218176\t\t \t\t\t10168507\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t CB68138\tCB68140\tCB69312\tCB69316\tCB69320\tCB69322 11827728\t11547343\tNo lot Manf\tNo lot Manf\t11760075\t11528256 11827753\t11349213\t\t\t11691777\t11315457 10930779\t10867471\t\t\t11641160\t11193464 10487797\t10832400\t\t\t11599810\t11150783 10479472\t10602831\t\t\t11561407\t10773261 10460369\t10558731\t\t\t11543093\t10762630 10380507\t10339014\t\t\t11538321\t10738036 10339011\t10318691\t\t\t11502623\t10652277 \t10278783\t\t\t11373282\t10651921 \t10168502\t\t\t11326470\t10651860 \t\t\t\t11315462\t10651858 \t\t\t\t11254882\t10185497 \t\t\t\t11182275\t \t\t\t\t11080563\t \t\t\t\t11058844\t \t\t\t\t11041189\t \t\t\t\t10992846\t \t\t\t\t10970854\t \t\t\t\t10960994\t \t\t\t\t10856294\t \t\t\t\t10832401\t \t\t\t\t10820613\t \t\t\t\t10806909\t \t\t\t\t10792661\t \t\t\t\t10699714\t \t\t\t\t10652270\t \t\t\t\t10613409\t \t\t\t\t10602834\t \t\t\t\t10577096\t \t\t\t\t10569655\t \t\t\t\t10542868\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t\t\t \t\t\t \t\t\t CB69324\tCB69328\tCB69331\tCB69428 10820614\t11627332\t11827735\t11827729 \t11610931\t11773404\t11114402 10843215\t11621107\t11584777\t11091706 \t11241603\t11547344\t10577076 10856298\t11231096\t11538288\t10552201 \t11193467\t11484933\t10542861 10901169\t11173265\t11154376\t10535597 \t11114381\t11075678\t10514262 10919620\t11091671\t10970856\t \t11075725\t10691434\t 10923638\t11041191\t10398312\t \t11007111\t10278845\t 10980890\t10980883\t10232689\t \t10960995 11028727\t10970855 \t10945758 11041190\t10923639 \t10901170 11050659\t10878788 \t10856296 11069171\t10843154 \t10820615 11114395\t10783535 \t10773263 11150794\t10751540 \t10613550 11182285\t10583504 \t10569681 11206048\t10261375 \t10176027 11241628\t \t 11278697\t \t 11338690\t \t 11349218\t \t 11538298\t \t 11538300\t \t 11543085\t \t 11584782\t  10186265  10261371  10487806  10494775  10503892  10514227  10542903  10683889  10721070  10738037  10751539  10773262  10792662  10806910", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management", "address_1": "8200 Coral Sea St. N.E.", "city": "Saint Paul", "state": "MN", "postal_code": "55112", "additional_info_contact": "763-526-6000", "reason_for_recall": "Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. \n\nMedtronic has received two reports of patient deaths due to p", "root_cause_description": "Labeling design", "action": "Medtronic sent an \"URGENT MEDICAL DEVICE INFORMATION\" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.", "product_quantity": "14,306", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.", "openfda": { "k_number": [ "K910021", "K884310", "K862190", "K032632", "K874899", "K895352", "K821316", "K143083", "K873212", "K961270", "K832475", "K092509", "K863740", "K120072", "K844138", "K883221", "K081820", "K905312", "K901074", "K863558", "K851323", "K810820", "K881072", "K860988", "K863342", "K874853", "K132995", "K062597", "K870507", "K012617", "K961245", "K150536", "K964195", "K180456", "K902394", "K802261", "K840001", "K861103", "K113459", "K201100", "K113869", "K031037", "K971291", "K090878", "K022174", "K964374", "K831332", "K113411", "K971019", "K152190", "K950814", "K003371", "K972261", "K844139", "K964373", "K060101", 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