FDA Device Recall Z-0877-2023

Covidien LP · Mansfield, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; 16cm, Straight Extensions, Kit - Model No. 8888135161; 16cm, Curved Extensions, Kit - Model No. 8888135162; 16 cm, Pre-Curved, Kit - Model No. 8888135163; 16cm, Straight Extensions, IC Tray - Model No. 8888135164; 19.5cm, Straight Extensions, Kit - Model No. 8888135191; 19.5cm, Curved Extensions, Kit - Model No. 8888135192; 19.5cm, Pre-Curved, Kit - Model No. 8888135193; 19.5cm, Straight Extensions, IC Tray - Model No. 8888135194; 19.5cm, Curved Extensions, PASS Tray - Model No. 8888135198; 24cm, Straight Extensions, Kit - Model No. 8888135241; 24cm, Curved Extensions, Kit - Model No. 8888135242; 24cm, Pre-Curved, Kit - Model No. 8888135243

Lot / serial / GTIN: Model no. 8888135131, UDI-DI (GTIN) 20884521006208, Serial Numbers/Lots 1812900083 1813500125 1813500126 1813500127 1815000125 1815700093 1817700163 1818500134 1818500135 1818500136 1825400151 1825400152 1825400153 1826200138 1826200139 1830300127 1932300176 2001400063 2003900121 2005700199 2006500068 2010800195 2011300093 2019500161 2110900061 2110900084 2113300229 - Model no. 8888135132 UDI-DI (GTIN) 20884521006215 Serial numbers/Lots 1807900113 1809200136 1809200143 1810200110 1812200142 1819000116 1819000117 1819000118 1820500152 1826200094 1831100160 1835100093 1904200111 1906700209 1907700101 1911300213 1912600120 1912600121 1912600122 1913000102 1913000103 1920500250 1920500251 1921300045 1921300046 1921300047 1921900187 1921900188 1933000076 1934300146 2000700099 2002900105 2002900126 2002900127 2006500069 2007800043 2010800193 2010800194 2015100037 2016000060 2016700073 2201800062 - Model No. 8888135133 UDI/DI (GTIN) 20884521006253 Serial Numbers/Lots 1801000105 1803100140 1803700085 1806500174 1807300109 1807900112 1808200161 1812200141 1831100170 1831100171 1831100179 1834500174 1835100099 1835300240 1901400135 1902100148 1902800125 1926800454 1927500097 1927500117 1931500108 2019500182 2023400141 2035000068 2035000069 2104200114 2106900053 2106900056 2110900129 2201800060 - Model No. 8888135134 UDI/DI (GTIN) 20884521006284 Serial Number/Lot 2128000086 - Model no. 8888135161 UDI-DI (GTIN) 20884521006352 Serial Numbers/Lots 1800300109 1801000106 1801600120 1802300090 1803700086 1804500111 1806500176 1807300110 1808500123 1809200137 1810000110 1811500137 1812200145 1812900084 1820500155 1820500157 1820500159 1821300101 1823900099 1826200140 1826800111 1827600097 1827600098 1828900079 1831100166 1831100172 1834500175 1834500185 1835100094 1900700154 1900700155 1901400129 1901400130 1901400132 1902100143 1903500131 1904900105 1908400352 1908400353 1908800226 1908800227 1910200079 1913000191 1913000192 1914000254 1914000255 1914000256 1914000257 1923200090 1923300078 1923400255 1923400258 1923400260 1923400264 1931600079 1931600080 1931600081 1931600082 1931600083 2006500073 2008000105 2102600085 2104200115 2106900055 2106900057 2106900063 2110900085 2110900130 2113300202 2113300204 2113300207 2113300209 2113300211 2113300212 2113300215 2113300231 2116600082 2201800068 2201800075 2201800085 - Model No. 8888135162 UDI/DI (GTIN) 20884521006376 Serial Numbers/Lots 1804500112 1805100083 1806500175 1808500121 1810000109 1810200111 1812200144 1812900082 1822000125 1822600139 1822600140 1822600141 1822600142 1823000086 1823400075 1823900136 1908400313 1908400314 1911300211 1911300212 1914400114 1914400115 1919900123 1926800455 1926800456 1926800457 1932300174 1932300175 2008400115 2015900059 2019500163 2019500167 2019500170 2019500183 2028300165 2113300234 2201800059 2203300143 - Model No. 8888135163 UDI/DI (GTIN) 20884521006383 Serial numbers/lots 1805100084 1805800137 1806500173 1808500122 1811500136 1815500095 1818500137 1822000124 1830300125 1831100155 1834500184 1835300223 1900700148 1908400315 1912600089 1921300063 1921300064 1923200092 1924600111 1924600113 1924600114 1926100250 1926100251 1926100252 2026100081 2027200027 2027200279 2028300085 2028300086 2035000070 2106900054 2106900059 2110900131 2113300220 2113300239 2116600135 2201700095 - Model No. 8888135164 UDI/DI (GTIN) 20884521006406 Serial number/lot 2200400119 - Model No. 8888135191 UDI/DI (GTIN) 20884521006444 Serial numbers/lots 1800300110 1801600121 1802300087 1805100085 1805800138 1806500177 1807300111 1807900111 1808500124 1809200138 1810000113 1810200109 1811500138 1812200139 1813500124 1813500128 1814300167 1814300168 1814300169 1814300170 1815000121 1815700094 1815700095 1816300079 1816300080 1817000104 1817000105 1817700161 1817700162 1823400079 1823900128 1824700111 1824700114 1824700115 1828200082 1828200099 1828200100 1828900080 1828900108 1828900109 1830300123 1831000084 1831100154 1831100156 1831100157 1831100158 1831100168 1831100173 1831100174 1902100152 1902100153 1902800147 1902800148 1902800149 1903500132 1904900118 1905600096 1905600097 1911600106 1911600107 1911600108 1911600109 1914400134 1914400135 1914800170 1916500149 1916500150 1916500151 1916500152 1917200301 1917200302 1917200304 1917200311 1917200313 1919800100 1919800101 1920500239 1920500240 1920500241 1927500118 1927500119 1928200057 1928200058 1928200059 1928200060 1928800179 1933000077 1933000078 1933000079 1934300147 1934300148 1934400196 1934400197 1934400198 2000700077 2000700078 2000700097 2003900120 2007800045 2007800091 2007800117 2009200098 2009300098 2009300099 2009300108 2009400123 2009400124 2010600087 2010600089 2010800192 2010800196 2010800197 2011300095 2015100036 2016300047 2016700068 2016700069 2019500179 2023400142 2023400143 2033100067 2035000071 2035000072 2035000073 2035000074 2102600087 2102600088 2102600089 2103400143 2103400144 2104200116 2104200117 2104200120 2104200122 2104200130 2104200131 2106900064 2106900117 2106900123 2106900183 2106900198 2106900217 2106900230 2110900060 2110900062 2110900083 2110900100 2110900132 2110900151 2110900152 2110900153 2110900161 2113300210 2113300213 2113300216 2113300218 2113300222 2113300224 2113300232 2113300238 2113300240 2116600113 2116600181 2116600183 2203300086 - Model No. 8888135192 UDI/DI (GTIN) 20884521006475 Serial numbers/lots 1810200112 1822000070 1823900126 1826200142 1826800101 1830300163 1905600134 1907800149 1912600088 1924000217 2009200099 2015100034 2016000062 2016300043 2019500176 2035000075 2035000076 2201800076 - Model no. 8888135193 UDI/DI (GTIN) 20884521006499 Serial numbers/lots 1810000111 1810200108 1811300114 1812200147 1812900086 1813500123 1815500094 1823400094 1823900106 1826800114 2034900048 2035000077 2035000078 - Model No. 8888135194 UDI/DI (GTIN) 20884521006505 Serial numbers/lots 2128000083 - Model No. 8888135198 UDI/DI (GTIN) 10884521057364 Serial numbers/lots 2123000182 - Model No. 8888135241 UDI/DI (GTIN) 20884521006536 Serial Numbers/lots 1812200143 1815000122 1815000123 1815000124 1816300081 1817000103 1821300104 1821300106 1828200081 1906000122 1906000123 1906000125 1906700164 1910200107 1910200108 1911300210 1914400136 1924000175 1924000177 1924000178 1924000180 1926100289 1926100290 1926700116 1931500114 1931600078 1934300145 2005700197 2005700198 2009300046 2016600056 2018000023 2018800039 2018800040 2018800041 2019500158 2019500159 2019500160 2020500069 2020500070 2020500071 2020500073 2020500074 2023400144 2103400145 2104200118 2104200119 2104200121 2106900060 2106900067 2106900111 2110900101 2110900160 2113300203 2113300217 2113300225 2113300241 2119400199 2201800072 2201800073 2201800079 2201800081 2203300075 - Model No. 8888135242 UDI/DI (GTIN) 20884521006543 Serial numbers/lots 1802300089 1802300094 1807900115 1809200141 1831100167 1905600133 1907800112 1908400342 2016300045 2019500180 2019500181 2113300219 - Model No. 8888135243 UDI/DI (GTIN) 20884521006550 Serial numbers/lots 1820500153 1824700198 2106900052

Quantity: 359,730 (23,003 US; 336,727 OUS)

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.

Recall record

Recall number: Z-0877-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2022-12-07
Classified by FDA Center: 2023-01-12
FDA published: 2023-01-18
Recalling firm: Covidien LP
Firm location: Mansfield, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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