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.
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. 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, Quantity: 359,730 (23,003 US; 336,727 OUS) Lot/code info: 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 180230009
20884521006208, 20884521006215, 20884521006253, 20884521006284, 20884521006352, 20884521006376, 20884521006383, 20884521006406, 20884521006444, 20884521006475, 20884521006499, 20884521006505, 10884521057364, 20884521006536, 20884521006543, 20884521006550
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.