{ "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": "197255", "product_res_number": "Z-0877-2023", "event_date_initiated": "2022-12-07", "event_date_posted": "2023-01-12", "recall_status": "Open, Classified", "res_event_number": "91206", "product_code": "NIE", "k_numbers": [ "K030209" ], "product_description": "MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: \n\n13.5cm, Straight Extensions, Kit - Model No. 8888135131; \n13.5 cm, Curved Extensions, Kit - Model No. 8888135132; \n13.5cm, Pre-Curved, Kit - Model No. 8888135133; \n13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; \n\n16cm, Straight Extensions, Kit - Model No. 8888135161; \n16cm, Curved Extensions, Kit - Model No. 8888135162; \n16 cm, Pre-Curved, Kit - Model No. 8888135163; \n16cm, Straight Extensions, IC Tray - Model No. 8888135164; \n\n19.5cm, Straight Extensions, Kit - Model No. 8888135191; \n19.5cm, Curved Extensions, Kit - Model No. 8888135192; \n19.5cm, Pre-Curved, Kit - Model No. 8888135193; \n19.5cm, Straight Extensions, IC Tray - Model No. 8888135194; \n19.5cm, Curved Extensions, PASS Tray - Model No. 8888135198; \n\n24cm, Straight Extensions, Kit - Model No. 8888135241; \n24cm, Curved Extensions, Kit - Model No. 8888135242; \n24cm, Pre-Curved, Kit - Model No. 8888135243", "code_info": "Model no. 8888135131, \nUDI-DI (GTIN) 20884521006208, \nSerial Numbers/Lots \n1812900083\n1813500125\n1813500126\n1813500127\n1815000125\n1815700093\n1817700163\n1818500134\n1818500135\n1818500136\n1825400151\n1825400152\n1825400153\n1826200138\n1826200139\n1830300127\n1932300176\n2001400063\n2003900121\n2005700199\n2006500068\n2010800195\n2011300093\n2019500161\n2110900061\n2110900084\n2113300229\n-\nModel no. 8888135132 \nUDI-DI (GTIN) 20884521006215 \nSerial numbers/Lots \n1807900113\n1809200136\n1809200143\n1810200110\n1812200142\n1819000116\n1819000117\n1819000118\n1820500152\n1826200094\n1831100160\n1835100093\n1904200111\n1906700209\n1907700101\n1911300213\n1912600120\n1912600121\n1912600122\n1913000102\n1913000103\n1920500250\n1920500251\n1921300045\n1921300046\n1921300047\n1921900187\n1921900188\n1933000076\n1934300146\n2000700099\n2002900105\n2002900126\n2002900127\n2006500069\n2007800043\n2010800193\n2010800194\n2015100037\n2016000060\n2016700073\n2201800062\n-\n\nModel No. 8888135133 \nUDI/DI (GTIN) 20884521006253 \nSerial Numbers/Lots \n1801000105\n1803100140\n1803700085\n1806500174\n1807300109\n1807900112\n1808200161\n1812200141\n1831100170\n1831100171\n1831100179\n1834500174\n1835100099\n1835300240\n1901400135\n1902100148\n1902800125\n1926800454\n1927500097\n1927500117\n1931500108\n2019500182\n2023400141\n2035000068\n2035000069\n2104200114\n2106900053\n2106900056\n2110900129\n2201800060\n-\n\nModel No. 8888135134 \nUDI/DI (GTIN) 20884521006284 \nSerial Number/Lot \n2128000086\n\n-\nModel no. 8888135161\nUDI-DI (GTIN) 20884521006352\nSerial Numbers/Lots\n1800300109\n1801000106\n1801600120\n1802300090\n1803700086\n1804500111\n1806500176\n1807300110\n1808500123\n1809200137\n1810000110\n1811500137\n1812200145\n1812900084\n1820500155\n1820500157\n1820500159\n1821300101\n1823900099\n1826200140\n1826800111\n1827600097\n1827600098\n1828900079\n1831100166\n1831100172\n1834500175\n1834500185\n1835100094\n1900700154\n1900700155\n1901400129\n1901400130\n1901400132\n1902100143\n1903500131\n1904900105\n1908400352\n1908400353\n1908800226\n1908800227\n1910200079\n1913000191\n1913000192\n1914000254\n1914000255\n1914000256\n1914000257\n1923200090\n1923300078\n1923400255\n1923400258\n1923400260\n1923400264\n1931600079\n1931600080\n1931600081\n1931600082\n1931600083\n2006500073\n2008000105\n2102600085\n2104200115\n2106900055\n2106900057\n2106900063\n2110900085\n2110900130\n2113300202\n2113300204\n2113300207\n2113300209\n2113300211\n2113300212\n2113300215\n2113300231\n2116600082\n2201800068\n2201800075\n2201800085\n-\n\nModel No. 8888135162 \nUDI/DI (GTIN) 20884521006376 \nSerial Numbers/Lots \n1804500112\n1805100083\n1806500175\n1808500121\n1810000109\n1810200111\n1812200144\n1812900082\n1822000125\n1822600139\n1822600140\n1822600141\n1822600142\n1823000086\n1823400075\n1823900136\n1908400313\n1908400314\n1911300211\n1911300212\n1914400114\n1914400115\n1919900123\n1926800455\n1926800456\n1926800457\n1932300174\n1932300175\n2008400115\n2015900059\n2019500163\n2019500167\n2019500170\n2019500183\n2028300165\n2113300234\n2201800059\n2203300143\n\n-\nModel No. 8888135163 \nUDI/DI (GTIN) 20884521006383 \nSerial numbers/lots\n1805100084\n1805800137\n1806500173\n1808500122\n1811500136\n1815500095\n1818500137\n1822000124\n1830300125\n1831100155\n1834500184\n1835300223\n1900700148\n1908400315\n1912600089\n1921300063\n1921300064\n1923200092\n1924600111\n1924600113\n1924600114\n1926100250\n1926100251\n1926100252\n2026100081\n2027200027\n2027200279\n2028300085\n2028300086\n2035000070\n2106900054\n2106900059\n2110900131\n2113300220\n2113300239\n2116600135\n2201700095\n-\n\nModel No. 8888135164 \nUDI/DI (GTIN) 20884521006406 \nSerial number/lot 2200400119\n\n-\n\nModel No. 8888135191 \nUDI/DI (GTIN) 20884521006444 \nSerial numbers/lots \n1800300110\n1801600121\n1802300087\n1805100085\n1805800138\n1806500177\n1807300111\n1807900111\n1808500124\n1809200138\n1810000113\n1810200109\n1811500138\n1812200139\n1813500124\n1813500128\n1814300167\n1814300168\n1814300169\n1814300170\n1815000121\n1815700094\n1815700095\n1816300079\n1816300080\n1817000104\n1817000105\n1817700161\n1817700162\n1823400079\n1823900128\n1824700111\n1824700114\n1824700115\n1828200082\n1828200099\n1828200100\n1828900080\n1828900108\n1828900109\n1830300123\n1831000084\n1831100154\n1831100156\n1831100157\n1831100158\n1831100168\n1831100173\n1831100174\n1902100152\n1902100153\n1902800147\n1902800148\n1902800149\n1903500132\n1904900118\n1905600096\n1905600097\n1911600106\n1911600107\n1911600108\n1911600109\n1914400134\n1914400135\n1914800170\n1916500149\n1916500150\n1916500151\n1916500152\n1917200301\n1917200302\n1917200304\n1917200311\n1917200313\n1919800100\n1919800101\n1920500239\n1920500240\n1920500241\n1927500118\n1927500119\n1928200057\n1928200058\n1928200059\n1928200060\n1928800179\n1933000077\n1933000078\n1933000079\n1934300147\n1934300148\n1934400196\n1934400197\n1934400198\n2000700077\n2000700078\n2000700097\n2003900120\n2007800045\n2007800091\n2007800117\n2009200098\n2009300098\n2009300099\n2009300108\n2009400123\n2009400124\n2010600087\n2010600089\n2010800192\n2010800196\n2010800197\n2011300095\n2015100036\n2016300047\n2016700068\n2016700069\n2019500179\n2023400142\n2023400143\n2033100067\n2035000071\n2035000072\n2035000073\n2035000074\n2102600087\n2102600088\n2102600089\n2103400143\n2103400144\n2104200116\n2104200117\n2104200120\n2104200122\n2104200130\n2104200131\n2106900064\n2106900117\n2106900123\n2106900183\n2106900198\n2106900217\n2106900230\n2110900060\n2110900062\n2110900083\n2110900100\n2110900132\n2110900151\n2110900152\n2110900153\n2110900161\n2113300210\n2113300213\n2113300216\n2113300218\n2113300222\n2113300224\n2113300232\n2113300238\n2113300240\n2116600113\n2116600181\n2116600183\n2203300086\n-\n\nModel No. 8888135192 \nUDI/DI (GTIN) 20884521006475 \nSerial numbers/lots \n1810200112\n1822000070\n1823900126\n1826200142\n1826800101\n1830300163\n1905600134\n1907800149\n1912600088\n1924000217\n2009200099\n2015100034\n2016000062\n2016300043\n2019500176\n2035000075\n2035000076\n2201800076\n-\n\nModel no. 8888135193 \nUDI/DI (GTIN) 20884521006499 \nSerial numbers/lots \n1810000111\n1810200108\n1811300114\n1812200147\n1812900086\n1813500123\n1815500094\n1823400094\n1823900106\n1826800114\n2034900048\n2035000077\n2035000078\n-\n\nModel No. 8888135194 \nUDI/DI (GTIN) 20884521006505 \nSerial numbers/lots 2128000083\n\n-\n\nModel No. 8888135198 \nUDI/DI (GTIN) 10884521057364 \nSerial numbers/lots 2123000182\n-\n\nModel No. 8888135241 \nUDI/DI (GTIN) 20884521006536 \nSerial Numbers/lots \n1812200143\n1815000122\n1815000123\n1815000124\n1816300081\n1817000103\n1821300104\n1821300106\n1828200081\n1906000122\n1906000123\n1906000125\n1906700164\n1910200107\n1910200108\n1911300210\n1914400136\n1924000175\n1924000177\n1924000178\n1924000180\n1926100289\n1926100290\n1926700116\n1931500114\n1931600078\n1934300145\n2005700197\n2005700198\n2009300046\n2016600056\n2018000023\n2018800039\n2018800040\n2018800041\n2019500158\n2019500159\n2019500160\n2020500069\n2020500070\n2020500071\n2020500073\n2020500074\n2023400144\n2103400145\n2104200118\n2104200119\n2104200121\n2106900060\n2106900067\n2106900111\n2110900101\n2110900160\n2113300203\n2113300217\n2113300225\n2113300241\n2119400199\n2201800072\n2201800073\n2201800079\n2201800081\n2203300075\n\n-\n\nModel No. 8888135242 \nUDI/DI (GTIN) 20884521006543 \nSerial numbers/lots \n1802300089\n1802300094\n1807900115\n1809200141\n1831100167\n1905600133\n1907800112\n1908400342\n2016300045\n2019500180\n2019500181\n2113300219\n-\n\nModel No. 8888135243 \nUDI/DI (GTIN) 20884521006550 \nSerial numbers/lots \n1820500153\n1824700198\n2106900052", "firm_fei_number": "1282497", "recalling_firm": "Covidien LP", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "Dori Estrella-Sands\n763-505-2670", "reason_for_recall": "There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.", "root_cause_description": "Process design", "action": "On December 7, 2022, Medtronic began notifying customers who had received the affected products.\n\nCustomers were instructed to quarantine, discontinue use, and return unused products.\n\nCustomers should forward the notification to those who need to be aware within the organization, and to any location where the devices have been distributed.", "product_quantity": "359,730 (23,003 US; 336,727 OUS)", "distribution_pattern": "Worldwide distribution. US nationwide including Guam, USVI, and Puerto Rico; Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, Italy, Jamaica, Kenya, Malaysia, Malta, Mauritius, Mexico, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, and United Kingdom.", "openfda": { "k_number": [ "K083675", "K183219", "K181175", "K020089", "K102605", "K133456", "K141531", "K123292", "K033570", "K222170", "K232945", "K143102" ], "device_name": "Catheter, Hemodialysis, Triple Lumen, Non-Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2", "registration_number": [ "3015859709", "3030574705", "2011171", "1018233", "3010882065", "2518902", "3009211636", "3009888344", "3006082230", "1000563940", "1282497", "1721676", "1319639", "9610849", "9617592", "3003915875", "2030624", "9680794", "3006260740", "3007544634" ], "fei_number": [ "3015859709", "3030574705", "1000138054", "2011171", "1018233", "2518902", "3009211636", "3006097687", "3009888344", "3006082230", "3002807391", "1000563940", "1282497", "1721676", "3003737899", "3003915875", "3000206435", "3007544634", "3006260740", "3002468371" ] } } ] }