Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Class I - Dangerous

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    Code Information organized as "Model No., Serial No., GTIN": 8888119362, 1928800230, 10884521056879; 8888119362, 1825400094, 20884521056876; 8888119362, 1912600107, 20884521056876; 8888119362, 1917600139, 20884521056876; 8888119362, 1917700080, 20884521056876; 8888119362, 1925200098, 20884521056876; 8888119362, 1927300146, 20884521056876; 8888119362, 1928800230, 20884521056876; 8888119362, 2023300144, 20884521056876; 8888119362, 2028200216, 20884521056876; 8888119362, 2122900239, 20884521056876; 8888119385, 1720700105, 20884521012421; 8888119385, 1724900109, 20884521012421; 8888119385, 2113300429, 20884521012421; 8888123402, 1927500121, 10884521056886; 8888123402, 2028200203, 10884521056886; 8888123402, 2110900059, 10884521056886; 8888123402, 1921700145, 20884521056883; 8888123402, 1924000138, 20884521056883; 8888123402, 1925200091, 20884521056883; 8888123402, 1927500120, 20884521056883; 8888123402, 1927500121, 20884521056883; 8888123402, 2023300143, 20884521056883; 8888123402, 2026000055, 20884521056883; 8888123402, 2028200203, 20884521056883; 8888123402, 2034400155, 20884521056883; 8888123402, 2104100105, 20884521056883; 8888123402, 2110900059, 20884521056883; 8888123402, 2113300432, 20884521056883; 8888123402, 2122900252, 20884521056883; 8888123435, 2034400156, 10884521012516; 8888123435, 1716500170, 20884521012513; 8888123435, 1716700115, 20884521012513; 8888123435, 1825400095, 20884521012513; 8888123435, 1831000101, 20884521012513; 8888123435, 2003700038, 20884521012513; 8888123435, 2034400156, 20884521012513; 8888123435, 2106900231, 20884521012513; 8888123435, 2113300430, 20884521012513; 8888128452, 2023300145, 10884521056916; 8888128452, 1716500171, 20884521056913; 8888128452, 1831000102, 20884521056913; 8888128452, 1904200079, 20884521056913; 8888128452, 2023300145, 20884521056913; 8888128485, 1716500172, 20884521012544; 8888128485, 1718600097, 20884521012544; 8888128485, 1720000119, 20884521012544; 8888133502, 1715100148, 20884521056920; 8888133535, 1924000139, 20884521013947; 8888145001, 1715800112, 10884521014084; 8888145001, 1722300112, 10884521014084; 8888145001, 1722600094, 10884521014084; 8888145001, 1723400093, 10884521014084; 8888145001, 1831000103, 10884521014084; 8888145001, 1904900119, 10884521014084; 8888145001, 1910200086, 10884521014084; 8888145001, 1912600085, 10884521014084; 8888145001, 1919700113, 10884521014084; 8888145001, 1925200099, 10884521014084; 8888145001, 2003700040, 10884521014084; 8888145001, 2008400137, 10884521014084; 8888145001, 2014900153, 10884521014084; 8888145001, 2014900166, 10884521014084; 8888145001, 2017500086, 10884521014084; 8888145001, 2017600091, 10884521014084; 8888145001, 2017600092, 10884521014084; 8888145001, 2017800060, 10884521014084; 8888145001, 1715300102, 20884521014081; 8888145001, 1715800112, 20884521014081; 8888145001, 1717200147, 20884521014081; 8888145001, 1717900143, 20884521014081; 8888145001, 1719300092, 20884521014081; 8888145001, 1720700107, 20884521014081; 8888145001, 1721300152, 20884521014081; 8888145001, 1722100148, 20884521014081; 8888145001, 1722300110, 20884521014081; 8888145001, 1722300111, 20884521014081; 8888145001, 1722300112, 20884521014081; 8888145001, 1722600094, 20884521014081; 8888145001, 1723400093, 20884521014081; 8888145001, 1723400094, 20884521014081; 8888145001, 1729100101, 20884521014081; 8888145001, 1810000171, 20884521014081; 8888145001, 1811500160, 20884521014081; 8888145001, 1827600114, 20884521014081; 8888145001, 1828200109, 20884521014081; 8888145001, 1829500106, 20884521014081; 8888145001, 1831000103, 20884521014081; 8888145001, 1834500194, 20884521014081; 8888145001, 1904200086, 20884521014081; 8888145001, 1904900119, 20884521014081; 8888145001, 1904900120, 20884521014081; 8888145001, 1905600120, 20884521014081; 8888145001, 1905600121, 20884521014081; 8888145001, 1906000118, 20884521014081; 8888145001, 1906000119, 20884521014081; 8888145001, 1910200086, 20884521014081; 8888145001, 1910200087, 20884521014081; 8888145001, 1910600255, 20884521014081; 8888145001, 1910600258, 20884521014081; 8888145001, 1912600085, 20884521014081; 8888145001, 1912600086, 20884521014081; 8888145001, 1919700113, 20884521014081; 8888145001, 1924000150, 20884521014081; 8888145001, 1925200099, 20884521014081; 8888145001, 2003700040, 20884521014081; 8888145001, 2008400137, 20884521014081; 8888145001, 2014900153, 20884521014081; 8888145001, 2014900164, 20884521014081; 8888145001, 2014900166, 20884521014081; 8888145001, 2014900167, 20884521014081; 8888145001, 2014900168, 20884521014081; 8888145001, 2014900169, 20884521014081; 8888145001, 2015300068, 20884521014081; 8888145001, 2017500086, 20884521014081; 8888145001, 2017600091, 20884521014081; 8888145001, 2017600092, 20884521014081; 8888145001, 2017800060, 20884521014081; 8888145001, 2124600201, 20884521014081; 8888145002, 1833100106, 10884521014145; 8888145002, 1914800162, 10884521014145; 8888145002, 1914800164, 10884521014145; 8888145002, 1920700130, 10884521014145; 8888145002, 2009300119, 10884521014145; 8888145002, 2027200195, 10884521014145; 8888145002, 2027200206, 10884521014145; 8888145002, 2034300098, 10884521014145; 8888145002, 1725100109, 20884521014142; 8888145002, 1728400115, 20884521014142; 8888145002, 1731200161, 20884521014142; 8888145002, 1732600137, 20884521014142; 8888145002, 1831600193, 20884521014142; 8888145002, 1833100106, 20884521014142; 8888145002, 1833800130, 20884521014142; 8888145002, 1906700180, 20884521014142; 8888145002, 1914400129, 20884521014142; 8888145002, 1914800162, 20884521014142; 8888145002, 1914800164, 20884521014142; 8888145002, 1917600065, 20884521014142; 8888145002, 1920700130, 20884521014142; 8888145002, 2009300119, 20884521014142; 8888145002, 2027200195, 20884521014142; 8888145002, 2027200206, 20884521014142; 8888145002, 2034300098, 20884521014142; 8888145003, 1727700140, 20884521014180; 8888145003, 1828900129, 20884521014180; 8888145003, 2001400108, 20884521014180; 8888145004, 1715100150, 20884521014203; 8888145004, 1725500097, 20884521014203; 8888145004, 1801000133, 20884521014203; 8888145027, 1720700106, 10884521056930; 8888145027, 1726300133, 10884521056930; 8888145027, 1805200080, 10884521056930; 8888145027, 1814300195, 10884521056930; 8888145027, 1822000073, 10884521056930; 8888145027, 1830300164, 10884521056930; 8888145027, 1926100268, 10884521056930; 8888145027, 1830300164, 20884521056937; 8888145027, 1916500080, 20884521056937; 8888145027, 1926100268, 20884521056937; 8888145027, 2003700043, 20884521056937; 8888145027, 2009300081, 20884521056937; 8888145027, 2026000074, 20884521056937; 8888145027, 2027300039, 20884521056937; 8888145027, 2034400151, 20884521056937; 8888145027, 2102500099, 20884521056937; 8888145027, 2104600166, 20884521056937; 8888145028, 1728400117, 10884521056947; 8888145028, 1805200081, 10884521056947; 8888145028, 1834500198, 10884521056947; 8888145028, 2034400152, 10884521056947; 8888145028, 2102500100, 10884521056947; 8888145028, 1834500198, 20884521056944; 8888145028, 1917600137, 20884521056944; 8888145028, 2002100143, 20884521056944; 8888145028, 2023300108, 20884521056944; 8888145028, 2031800136, 20884521056944; 8888145028, 2034400152, 20884521056944; 8888145028, 2102500100, 20884521056944; 8888145028, 2124600209, 20884521056944; 8888145029, 2031800133, 20884521056951; 8888145029, 2034400153, 20884521056951; 8888145030, 1729700114, 20884521056968; 8888145251, 1715100151, 10884521014220; 8888145251, 1715800113, 10884521014220; 8888145251, 1716500173, 10884521014220; 8888145251, 1717500004, 10884521014220; 8888145251, 1717900144, 10884521014220; 8888145251, 1718600098, 10884521014220; 8888145251, 1719300093, 10884521014220; 8888145251, 1720000120, 10884521014220; 8888145251, 1720700108, 10884521014220; 8888145251, 1721300153, 10884521014220; 8888145251, 1723400095, 10884521014220; 8888145251, 1727100080, 10884521014220; 8888145251, 1727700141, 10884521014220; 8888145251, 1731900229, 10884521014220; 8888145251, 1732600131, 10884521014220; 8888145251, 1733300154, 10884521014220; 8888145251, 1733700133, 10884521014220; 8888145251, 1733700188, 10884521014220; 8888145251, 1734700109, 10884521014220; 8888145251, 1800300132, 10884521014220; 8888145251, 1800300140, 10884521014220; 8888145251, 1805200106, 10884521014220; 8888145251, 1806600084, 10884521014220; 8888145251, 1808600071, 10884521014220; 8888145251, 1812900138, 10884521014220; 8888145251, 1812900139, 10884521014220; 8888145251, 1814600080, 10884521014220; 8888145251, 1827600117, 10884521014220; 8888145251, 1827600118, 10884521014220; 8888145251, 1831600195, 10884521014220; 8888145251, 1831600196, 10884521014220; 8888145251, 1833800140, 10884521014220; 8888145251, 1834500196, 10884521014220; 8888145251, 1834500206, 10884521014220; 8888145251, 1835100102, 10884521014220; 8888145251, 1835300203, 10884521014220; 8888145251, 1913000094, 10884521014220; 8888145251, 1914000293, 10884521014220; 8888145251, 1914000294, 10884521014220; 8888145251, 1914400122, 10884521014220; 8888145251, 1916500098, 10884521014220; 8888145251, 1916500099, 10884521014220; 8888145251, 1916500100, 10884521014220; 8888145251, 1926100264, 10884521014220; 8888145251, 1926100265, 10884521014220; 8888145251, 1926100266, 10884521014220; 8888145251, 1934400191, 10884521014220; 8888145251, 1934400192, 10884521014220; 8888145251, 2002100144, 10884521014220; 8888145251, 2014900172, 10884521014220; 8888145251, 2017500089, 10884521014220; 8888145251, 2017500132, 10884521014220; 8888145251, 2017500137, 10884521014220; 8888145251, 2019500267, 10884521014220; 8888145251, 2021000067, 10884521014220; 8888145251, 2021000068, 10884521014220; 8888145251, 2023300104, 10884521014220; 8888145251, 2034400176, 10884521014220; 8888145251, 2106900163, 10884521014220; 8888145251, 2106900204, 10884521014220; 8888145251, 2113300431, 10884521014220; 8888145251, 1715100151, 20884521014227; 8888145251, 1715800113, 20884521014227; 8888145251, 1716500173, 20884521014227; 8888145251, 1717500004, 20884521014227; 8888145251, 1717900144, 20884521014227; 8888145251, 1718600098, 20884521014227; 8888145251, 1719300093, 20884521014227; 8888145251, 1720000120, 20884521014227; 8888145251, 1720700108, 20884521014227; 8888145251, 1721300153, 20884521014227; 8888145251, 1723400095, 20884521014227; 8888145251, 1727100080, 20884521014227; 8888145251, 1727700141, 20884521014227; 8888145251, 1731900229, 20884521014227; 8888145251, 1732600131, 20884521014227; 8888145251, 1733300154, 20884521014227; 8888145251, 1733700133, 20884521014227; 8888145251, 1733700188, 20884521014227; 8888145251, 1734700109, 20884521014227; 8888145251, 1800300132, 20884521014227; 8888145251, 1800300140, 20884521014227; 8888145251, 1805200106, 20884521014227; 8888145251, 1806600084, 20884521014227; 8888145251, 1808600071, 20884521014227; 8888145251, 1812900138, 20884521014227; 8888145251, 1812900139, 20884521014227; 8888145251, 1814600080, 20884521014227; 8888145251, 1827600117, 20884521014227; 8888145251, 1827600118, 20884521014227; 8888145251, 1831600195, 20884521014227; 8888145251, 1831600196, 20884521014227; 8888145251, 1834500206, 20884521014227; 8888145251, 1835100102, 20884521014227; 8888145251, 1835300203, 20884521014227; 8888145251, 1913000094, 20884521014227; 8888145251, 1914000293, 20884521014227; 8888145251, 1914000294, 20884521014227; 8888145251, 1914400122, 20884521014227; 8888145251, 1914400123, 20884521014227; 8888145251, 1916500098, 20884521014227; 8888145251, 1916500099, 20884521014227; 8888145251, 1916500100, 20884521014227; 8888145251, 1926100264, 20884521014227; 8888145251, 1926100265, 20884521014227; 8888145251, 1926100266, 20884521014227; 8888145251, 1934400191, 20884521014227; 8888145251, 1934400192, 20884521014227; 8888145251, 2002100144, 20884521014227; 8888145251, 2008400141, 20884521014227; 8888145251, 2014900158, 20884521014227; 8888145251, 2014900172, 20884521014227; 8888145251, 2017500089, 20884521014227; 8888145251, 2017500132, 20884521014227; 8888145251, 2017500137, 20884521014227; 8888145251, 2019500267, 20884521014227; 8888145251, 2021000067, 20884521014227; 8888145251, 2021000068, 20884521014227; 8888145251, 2023300104, 20884521014227; 8888145251, 2034400174, 20884521014227; 8888145251, 2034400175, 20884521014227; 8888145251, 2034400176, 20884521014227; 8888145251, 2106900163, 20884521014227; 8888145251, 2106900204, 20884521014227; 8888145251, 2110900089, 20884521014227; 8888145251, 2113300431, 20884521014227; 8888145251, 2124600198, 20884521014227; 8888145251, 2201800126, 20884521014227; 8888145252, 1715100152, 10884521014244; 8888145252, 1717900145, 10884521014244; 8888145252, 1719300094, 10884521014244; 8888145252, 1720000121, 10884521014244; 8888145252, 1720700109, 10884521014244; 8888145252, 1721300168, 10884521014244; 8888145252, 1724300117, 10884521014244; 8888145252, 1727700139, 10884521014244; 8888145252, 1728400118, 10884521014244; 8888145252, 1729700117, 10884521014244; 8888145252, 1732700130, 10884521014244; 8888145252, 1801700129, 10884521014244; 8888145252, 1803100113, 10884521014244; 8888145252, 1803800135, 10884521014244; 8888145252, 1805900114, 10884521014244; 8888145252, 1805900133, 10884521014244; 8888145252, 1806600083, 10884521014244; 8888145252, 1807300175, 10884521014244; 8888145252, 1808600069, 10884521014244; 8888145252, 1811500157, 10884521014244; 8888145252, 1813600094, 10884521014244; 8888145252, 1817100080, 10884521014244; 8888145252, 1826200145, 10884521014244; 8888145252, 1826200167, 10884521014244; 8888145252, 1826800153, 10884521014244; 8888145252, 1828200107, 10884521014244; 8888145252, 1828200108, 10884521014244; 8888145252, 1828900131, 10884521014244; 8888145252, 1828900139, 10884521014244; 8888145252, 1828900140, 10884521014244; 8888145252, 1829500126, 10884521014244; 8888145252, 1830300140, 10884521014244; 8888145252, 1832300104, 10884521014244; 8888145252, 1832300105, 10884521014244; 8888145252, 1833100107, 10884521014244; 8888145252, 1833800142, 10884521014244; 8888145252, 1907800084, 10884521014244; 8888145252, 1907800085, 10884521014244; 8888145252, 1908400301, 10884521014244; 8888145252, 1913000179, 10884521014244; 8888145252, 1913000180, 10884521014244; 8888145252, 1913000181, 10884521014244; 8888145252, 1914000241, 10884521014244; 8888145252, 1914800206, 10884521014244; 8888145252, 1915800101, 10884521014244; 8888145252, 1917200226, 10884521014244; 8888145252, 1935100108, 10884521014244; 8888145252, 1935100109, 10884521014244; 8888145252, 2002900149, 10884521014244; 8888145252, 2009300077, 10884521014244; 8888145252, 2014900160, 10884521014244; 8888145252, 2015400078, 10884521014244; 8888145252, 2019500178, 10884521014244; 8888145252, 2019500270, 10884521014244; 8888145252, 2020400103, 10884521014244; 8888145252, 2020400104, 10884521014244; 8888145252, 2023300107, 10884521014244; 8888145252, 2027200208, 10884521014244; 8888145252, 2028000088, 10884521014244; 8888145252, 2030300103, 10884521014244; 8888145252, 2034400173, 10884521014244; 8888145252, 2104600208, 10884521014244; 8888145252, 2104600211, 10884521014244; 8888145252, 2104800077, 10884521014244; 8888145252, 2106900104, 10884521014244; 8888145252, 1717900145, 20884521014241; 8888145252, 1719300094, 20884521014241; 8888145252, 1720000121, 20884521014241; 8888145252, 1720700109, 20884521014241; 8888145252, 1721300168, 20884521014241; 8888145252, 1724300117, 20884521014241; 8888145252, 1727700139, 20884521014241; 8888145252, 1728400118, 20884521014241; 8888145252, 1800400103, 20884521014241; 8888145252, 1801700129, 20884521014241; 8888145252, 1805900114, 20884521014241; 8888145252, 1805900133, 20884521014241; 8888145252, 1806600083, 20884521014241; 8888145252, 1807300175, 20884521014241; 8888145252, 1808600069, 20884521014241; 8888145252, 1811500157, 20884521014241; 8888145252, 1813600094, 20884521014241; 8888145252, 1817100080, 20884521014241; 8888145252, 1826200167, 20884521014241; 8888145252, 1826800153, 20884521014241; 8888145252, 1828200107, 20884521014241; 8888145252, 1828200108, 20884521014241; 8888145252, 1828900140, 20884521014241; 8888145252, 1829500126, 20884521014241; 8888145252, 1830300140, 20884521014241; 8888145252, 1832300104, 20884521014241; 8888145252, 1832300105, 20884521014241; 8888145252, 1833100107, 20884521014241; 8888145252, 1833800142, 20884521014241; 8888145252, 1907800085, 20884521014241; 8888145252, 1908400301, 20884521014241; 8888145252, 1913000179, 20884521014241; 8888145252, 1913000180, 20884521014241; 8888145252, 1913000181, 20884521014241; 8888145252, 1914000241, 20884521014241; 8888145252, 1914800206, 20884521014241; 8888145252, 1915800101, 20884521014241; 8888145252, 1917200226, 20884521014241; 8888145252, 1935100108, 20884521014241; 8888145252, 1935100109, 20884521014241; 8888145252, 2002900149, 20884521014241; 8888145252, 2009300077, 20884521014241; 8888145252, 2014900160, 20884521014241; 8888145252, 2015400078, 20884521014241; 8888145252, 2019500174, 20884521014241; 8888145252, 2019500178, 20884521014241; 8888145252, 2019500270, 20884521014241; 8888145252, 2020400103, 20884521014241; 8888145252, 2020400104, 20884521014241; 8888145252, 2023300107, 20884521014241; 8888145252, 2027200208, 20884521014241; 8888145252, 2028000088, 20884521014241; 8888145252, 2030300103, 20884521014241; 8888145252, 2034400154, 20884521014241; 8888145252, 2034400173, 20884521014241; 8888145252, 2104100103, 20884521014241; 8888145252, 2104600208, 20884521014241; 8888145252, 2104600211, 20884521014241; 8888145252, 2104800077, 20884521014241; 8888145252, 2106900104, 20884521014241; 8888145252, 2124600211, 20884521014241; 8888145253, 1715800114, 10884521014275; 8888145253, 1716500174, 10884521014275; 8888145253, 1717200148, 10884521014275; 8888145253, 1717900197, 10884521014275; 8888145253, 1718600099, 10884521014275; 8888145253, 1719300095, 10884521014275; 8888145253, 1720000122, 10884521014275; 8888145253, 1721300154, 10884521014275; 8888145253, 1817700211, 10884521014275; 8888145253, 1828900082, 10884521014275; 8888145253, 1829500105, 10884521014275; 8888145253, 1829500127, 10884521014275; 8888145253, 1832300107, 10884521014275; 8888145253, 1833100105, 10884521014275; 8888145253, 1833800129, 10884521014275; 8888145253, 1917600122, 10884521014275; 8888145253, 1926100269, 10884521014275; 8888145253, 2026000061, 10884521014275; 8888145253, 2027200253, 10884521014275; 8888145253, 2102500101, 10884521014275; 8888145253, 2104100104, 10884521014275; 8888145253, 2124600200, 10884521014275; 8888145253, 1715800114, 20884521014272; 8888145253, 1716500174, 20884521014272; 8888145253, 1717200148, 20884521014272; 8888145253, 1717900197, 20884521014272; 8888145253, 1718600099, 20884521014272; 8888145253, 1719300095, 20884521014272; 8888145253, 1720000122, 20884521014272; 8888145253, 1721300154, 20884521014272; 8888145253, 1817700211, 20884521014272; 8888145253, 1829500127, 20884521014272; 8888145253, 1832300107, 20884521014272; 8888145253, 1833100105, 20884521014272; 8888145253, 1917600122, 20884521014272; 8888145253, 1926100269, 20884521014272; 8888145253, 2027200253, 20884521014272; 8888145253, 2102500101, 20884521014272; 8888145253, 2124600200, 20884521014272; 8888145254, 1715800115, 10884521014329; 8888145254, 1716500175, 10884521014329; 8888145254, 1717800131, 10884521014329; 8888145254, 1717900146, 10884521014329; 8888145254, 1718600100, 10884521014329; 8888145254, 1719300096, 10884521014329; 8888145254, 1720500101, 10884521014329; 8888145254, 1833100104, 10884521014329; 8888145254, 1835300224, 10884521014329; 8888145254, 1903500127, 10884521014329; 8888145254, 1917200227, 10884521014329; 8888145254, 2027200201, 10884521014329; 8888145254, 1715800115, 20884521014326; 8888145254, 1716500175, 20884521014326; 8888145254, 1717800131, 20884521014326; 8888145254, 1717900146, 20884521014326; 8888145254, 1718600100, 20884521014326; 8888145254, 1719300096, 20884521014326; 8888145254, 1720500101, 20884521014326; 8888145254, 1720700110, 20884521014326; 8888145254, 1833100104, 20884521014326; 8888145254, 1835300224, 20884521014326; 8888145254, 1903500127, 20884521014326
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Covidien Llc
Reason for Recall:
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Product Codes/Lot Numbers:

Code Information organized as "Model No., Serial No., GTIN": 8888119362, 1928800230, 10884521056879; 8888119362, 1825400094, 20884521056876; 8888119362, 1912600107, 20884521056876; 8888119362, 1917600139, 20884521056876; 8888119362, 1917700080, 20884521056876; 8888119362, 1925200098, 20884521056876; 8888119362, 1927300146, 20884521056876; 8888119362, 1928800230, 20884521056876; 8888119362, 2023300144, 20884521056876; 8888119362, 2028200216, 20884521056876; 8888119362, 2122900239, 20884521056876; 8888119385, 1720700105, 20884521012421; 8888119385, 1724900109, 20884521012421; 8888119385, 2113300429, 20884521012421; 8888123402, 1927500121, 10884521056886; 8888123402, 2028200203, 10884521056886; 8888123402, 2110900059, 10884521056886; 8888123402, 1921700145, 20884521056883; 8888123402, 1924000138, 20884521056883; 8888123402, 1925200091, 20884521056883; 8888123402, 1927500120, 20884521056883; 8888123402, 1927500121, 20884521056883; 8888123402, 2023300143, 20884521056883; 8888123402, 2026000055, 20884521056883; 8888123402, 2028200203, 20884521056883; 8888123402, 2034400155, 20884521056883; 8888123402, 2104100105, 20884521056883; 8888123402, 2110900059, 20884521056883; 8888123402, 2113300432, 20884521056883; 8888123402, 2122900252, 20884521056883; 8888123435, 2034400156, 10884521012516; 8888123435, 1716500170, 20884521012513; 8888123435, 1716700115, 20884521012513; 8888123435, 1825400095, 20884521012513; 8888123435, 1831000101, 20884521012513; 8888123435, 2003700038, 20884521012513; 8888123435, 2034400156, 20884521012513; 8888123435, 2106900231, 20884521012513; 8888123435, 2113300430, 20884521012513; 8888128452, 2023300145, 10884521056916; 8888128452, 1716500171, 20884521056913; 8888128452, 1831000102, 20884521056913; 8888128452, 1904200079, 20884521056913; 8888128452, 2023300145, 20884521056913; 8888128485, 1716500172, 20884521012544; 8888128485, 1718600097, 20884521012544; 8888128485, 1720000119, 20884521012544; 8888133502, 1715100148, 20884521056920; 8888133535, 1924000139, 20884521013947; 8888145001, 1715800112, 10884521014084; 8888145001, 1722300112, 10884521014084; 8888145001, 1722600094, 10884521014084; 8888145001, 1723400093, 10884521014084; 8888145001, 1831000103, 10884521014084; 8888145001, 1904900119, 10884521014084; 8888145001, 1910200086, 10884521014084; 8888145001, 1912600085, 10884521014084; 8888145001, 1919700113, 10884521014084; 8888145001, 1925200099, 10884521014084; 8888145001, 2003700040, 10884521014084; 8888145001, 2008400137, 10884521014084; 8888145001, 2014900153, 10884521014084; 8888145001, 2014900166, 10884521014084; 8888145001, 2017500086, 10884521014084; 8888145001, 2017600091, 10884521014084; 8888145001, 2017600092, 10884521014084; 8888145001, 2017800060, 10884521014084; 8888145001, 1715300102, 20884521014081; 8888145001, 1715800112, 20884521014081; 8888145001, 1717200147, 20884521014081; 8888145001, 1717900143, 20884521014081; 8888145001, 1719300092, 20884521014081; 8888145001, 1720700107, 20884521014081; 8888145001, 1721300152, 20884521014081; 8888145001, 1722100148, 20884521014081; 8888145001, 1722300110, 20884521014081; 8888145001, 1722300111, 20884521014081; 8888145001, 1722300112, 20884521014081; 8888145001, 1722600094, 20884521014081; 8888145001, 1723400093, 20884521014081; 8888145001, 1723400094, 20884521014081; 8888145001, 1729100101, 20884521014081; 8888145001, 1810000171, 20884521014081; 8888145001, 1811500160, 20884521014081; 8888145001, 1827600114, 20884521014081; 8888145001, 1828200109, 20884521014081; 8888145001, 1829500106, 20884521014081; 8888145001, 1831000103, 20884521014081; 8888145001, 1834500194, 20884521014081; 8888145001, 1904200086, 20884521014081; 8888145001, 1904900119, 20884521014081; 8888145001, 1904900120, 20884521014081; 8888145001, 1905600120, 20884521014081; 8888145001, 1905600121, 20884521014081; 8888145001, 1906000118, 20884521014081; 8888145001, 1906000119, 20884521014081; 8888145001, 1910200086, 20884521014081; 8888145001, 1910200087, 20884521014081; 8888145001, 1910600255, 20884521014081; 8888145001, 1910600258, 20884521014081; 8888145001, 1912600085, 20884521014081; 8888145001, 1912600086, 20884521014081; 8888145001, 1919700113, 20884521014081; 8888145001, 1924000150, 20884521014081; 8888145001, 1925200099, 20884521014081; 8888145001, 2003700040, 20884521014081; 8888145001, 2008400137, 20884521014081; 8888145001, 2014900153, 20884521014081; 8888145001, 2014900164, 20884521014081; 8888145001, 2014900166, 20884521014081; 8888145001, 2014900167, 20884521014081; 8888145001, 2014900168, 20884521014081; 8888145001, 2014900169, 20884521014081; 8888145001, 2015300068, 20884521014081; 8888145001, 2017500086, 20884521014081; 8888145001, 2017600091, 20884521014081; 8888145001, 2017600092, 20884521014081; 8888145001, 2017800060, 20884521014081; 8888145001, 2124600201, 20884521014081; 8888145002, 1833100106, 10884521014145; 8888145002, 1914800162, 10884521014145; 8888145002, 1914800164, 10884521014145; 8888145002, 1920700130, 10884521014145; 8888145002, 2009300119, 10884521014145; 8888145002, 2027200195, 10884521014145; 8888145002, 2027200206, 10884521014145; 8888145002, 2034300098, 10884521014145; 8888145002, 1725100109, 20884521014142; 8888145002, 1728400115, 20884521014142; 8888145002, 1731200161, 20884521014142; 8888145002, 1732600137, 20884521014142; 8888145002, 1831600193, 20884521014142; 8888145002, 1833100106, 20884521014142; 8888145002, 1833800130, 20884521014142; 8888145002, 1906700180, 20884521014142; 8888145002, 1914400129, 20884521014142; 8888145002, 1914800162, 20884521014142; 8888145002, 1914800164, 20884521014142; 8888145002, 1917600065, 20884521014142; 8888145002, 1920700130, 20884521014142; 8888145002, 2009300119, 20884521014142; 8888145002, 2027200195, 20884521014142; 8888145002, 2027200206, 20884521014142; 8888145002, 2034300098, 20884521014142; 8888145003, 1727700140, 20884521014180; 8888145003, 1828900129, 20884521014180; 8888145003, 2001400108, 20884521014180; 8888145004, 1715100150, 20884521014203; 8888145004, 1725500097, 20884521014203; 8888145004, 1801000133, 20884521014203; 8888145027, 1720700106, 10884521056930; 8888145027, 1726300133, 10884521056930; 8888145027, 1805200080, 10884521056930; 8888145027, 1814300195, 10884521056930; 8888145027, 1822000073, 10884521056930; 8888145027, 1830300164, 10884521056930; 8888145027, 1926100268, 10884521056930; 8888145027, 1830300164, 20884521056937; 8888145027, 1916500080, 20884521056937; 8888145027, 1926100268, 20884521056937; 8888145027, 2003700043, 20884521056937; 8888145027, 2009300081, 20884521056937; 8888145027, 2026000074, 20884521056937; 8888145027, 2027300039, 20884521056937; 8888145027, 2034400151, 20884521056937; 8888145027, 2102500099, 20884521056937; 8888145027, 2104600166, 20884521056937; 8888145028, 1728400117, 10884521056947; 8888145028, 1805200081, 10884521056947; 8888145028, 1834500198, 10884521056947; 8888145028, 2034400152, 10884521056947; 8888145028, 2102500100, 10884521056947; 8888145028, 1834500198, 20884521056944; 8888145028, 1917600137, 20884521056944; 8888145028, 2002100143, 20884521056944; 8888145028, 2023300108, 20884521056944; 8888145028, 2031800136, 20884521056944; 8888145028, 2034400152, 20884521056944; 8888145028, 2102500100, 20884521056944; 8888145028, 2124600209, 20884521056944; 8888145029, 2031800133, 20884521056951; 8888145029, 2034400153, 20884521056951; 8888145030, 1729700114, 20884521056968; 8888145251, 1715100151, 10884521014220; 8888145251, 1715800113, 10884521014220; 8888145251, 1716500173, 10884521014220; 8888145251, 1717500004, 10884521014220; 8888145251, 1717900144, 10884521014220; 8888145251, 1718600098, 10884521014220; 8888145251, 1719300093, 10884521014220; 8888145251, 1720000120, 10884521014220; 8888145251, 1720700108, 10884521014220; 8888145251, 1721300153, 10884521014220; 8888145251, 1723400095, 10884521014220; 8888145251, 1727100080, 10884521014220; 8888145251, 1727700141, 10884521014220; 8888145251, 1731900229, 10884521014220; 8888145251, 1732600131, 10884521014220; 8888145251, 1733300154, 10884521014220; 8888145251, 1733700133, 10884521014220; 8888145251, 1733700188, 10884521014220; 8888145251, 1734700109, 10884521014220; 8888145251, 1800300132, 10884521014220; 8888145251, 1800300140, 10884521014220; 8888145251, 1805200106, 10884521014220; 8888145251, 1806600084, 10884521014220; 8888145251, 1808600071, 10884521014220; 8888145251, 1812900138, 10884521014220; 8888145251, 1812900139, 10884521014220; 8888145251, 1814600080, 10884521014220; 8888145251, 1827600117, 10884521014220; 8888145251, 1827600118, 10884521014220; 8888145251, 1831600195, 10884521014220; 8888145251, 1831600196, 10884521014220; 8888145251, 1833800140, 10884521014220; 8888145251, 1834500196, 10884521014220; 8888145251, 1834500206, 10884521014220; 8888145251, 1835100102, 10884521014220; 8888145251, 1835300203, 10884521014220; 8888145251, 1913000094, 10884521014220; 8888145251, 1914000293, 10884521014220; 8888145251, 1914000294, 10884521014220; 8888145251, 1914400122, 10884521014220; 8888145251, 1916500098, 10884521014220; 8888145251, 1916500099, 10884521014220; 8888145251, 1916500100, 10884521014220; 8888145251, 1926100264, 10884521014220; 8888145251, 1926100265, 10884521014220; 8888145251, 1926100266, 10884521014220; 8888145251, 1934400191, 10884521014220; 8888145251, 1934400192, 10884521014220; 8888145251, 2002100144, 10884521014220; 8888145251, 2014900172, 10884521014220; 8888145251, 2017500089, 10884521014220; 8888145251, 2017500132, 10884521014220; 8888145251, 2017500137, 10884521014220; 8888145251, 2019500267, 10884521014220; 8888145251, 2021000067, 10884521014220; 8888145251, 2021000068, 10884521014220; 8888145251, 2023300104, 10884521014220; 8888145251, 2034400176, 10884521014220; 8888145251, 2106900163, 10884521014220; 8888145251, 2106900204, 10884521014220; 8888145251, 2113300431, 10884521014220; 8888145251, 1715100151, 20884521014227; 8888145251, 1715800113, 20884521014227; 8888145251, 1716500173, 20884521014227; 8888145251, 1717500004, 20884521014227; 8888145251, 1717900144, 20884521014227; 8888145251, 1718600098, 20884521014227; 8888145251, 1719300093, 20884521014227; 8888145251, 1720000120, 20884521014227; 8888145251, 1720700108, 20884521014227; 8888145251, 1721300153, 20884521014227; 8888145251, 1723400095, 20884521014227; 8888145251, 1727100080, 20884521014227; 8888145251, 1727700141, 20884521014227; 8888145251, 1731900229, 20884521014227; 8888145251, 1732600131, 20884521014227; 8888145251, 1733300154, 20884521014227; 8888145251, 1733700133, 20884521014227; 8888145251, 1733700188, 20884521014227; 8888145251, 1734700109, 20884521014227; 8888145251, 1800300132, 20884521014227; 8888145251, 1800300140, 20884521014227; 8888145251, 1805200106, 20884521014227; 8888145251, 1806600084, 20884521014227; 8888145251, 1808600071, 20884521014227; 8888145251, 1812900138, 20884521014227; 8888145251, 1812900139, 20884521014227; 8888145251, 1814600080, 20884521014227; 8888145251, 1827600117, 20884521014227; 8888145251, 1827600118, 20884521014227; 8888145251, 1831600195, 20884521014227; 8888145251, 1831600196, 20884521014227; 8888145251, 1834500206, 20884521014227; 8888145251, 1835100102, 20884521014227; 8888145251, 1835300203, 20884521014227; 8888145251, 1913000094, 20884521014227; 8888145251, 1914000293, 20884521014227; 8888145251, 1914000294, 20884521014227; 8888145251, 1914400122, 20884521014227; 8888145251, 1914400123, 20884521014227; 8888145251, 1916500098, 20884521014227; 8888145251, 1916500099, 20884521014227; 8888145251, 1916500100, 20884521014227; 8888145251, 1926100264, 20884521014227; 8888145251, 1926100265, 20884521014227; 8888145251, 1926100266, 20884521014227; 8888145251, 1934400191, 20884521014227; 8888145251, 1934400192, 20884521014227; 8888145251, 2002100144, 20884521014227; 8888145251, 2008400141, 20884521014227; 8888145251, 2014900158, 20884521014227; 8888145251, 2014900172, 20884521014227; 8888145251, 2017500089, 20884521014227; 8888145251, 2017500132, 20884521014227; 8888145251, 2017500137, 20884521014227; 8888145251, 2019500267, 20884521014227; 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8888145252, 1803800135, 10884521014244; 8888145252, 1805900114, 10884521014244; 8888145252, 1805900133, 10884521014244; 8888145252, 1806600083, 10884521014244; 8888145252, 1807300175, 10884521014244; 8888145252, 1808600069, 10884521014244; 8888145252, 1811500157, 10884521014244; 8888145252, 1813600094, 10884521014244; 8888145252, 1817100080, 10884521014244; 8888145252, 1826200145, 10884521014244; 8888145252, 1826200167, 10884521014244; 8888145252, 1826800153, 10884521014244; 8888145252, 1828200107, 10884521014244; 8888145252, 1828200108, 10884521014244; 8888145252, 1828900131, 10884521014244; 8888145252, 1828900139, 10884521014244; 8888145252, 1828900140, 10884521014244; 8888145252, 1829500126, 10884521014244; 8888145252, 1830300140, 10884521014244; 8888145252, 1832300104, 10884521014244; 8888145252, 1832300105, 10884521014244; 8888145252, 1833100107, 10884521014244; 8888145252, 1833800142, 10884521014244; 8888145252, 1907800084, 10884521014244; 8888145252, 1907800085, 10884521014244; 8888145252, 1908400301, 10884521014244; 8888145252, 1913000179, 10884521014244; 8888145252, 1913000180, 10884521014244; 8888145252, 1913000181, 10884521014244; 8888145252, 1914000241, 10884521014244; 8888145252, 1914800206, 10884521014244; 8888145252, 1915800101, 10884521014244; 8888145252, 1917200226, 10884521014244; 8888145252, 1935100108, 10884521014244; 8888145252, 1935100109, 10884521014244; 8888145252, 2002900149, 10884521014244; 8888145252, 2009300077, 10884521014244; 8888145252, 2014900160, 10884521014244; 8888145252, 2015400078, 10884521014244; 8888145252, 2019500178, 10884521014244; 8888145252, 2019500270, 10884521014244; 8888145252, 2020400103, 10884521014244; 8888145252, 2020400104, 10884521014244; 8888145252, 2023300107, 10884521014244; 8888145252, 2027200208, 10884521014244; 8888145252, 2028000088, 10884521014244; 8888145252, 2030300103, 10884521014244; 8888145252, 2034400173, 10884521014244; 8888145252, 2104600208, 10884521014244; 8888145252, 2104600211, 10884521014244; 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8888145252, 1829500126, 20884521014241; 8888145252, 1830300140, 20884521014241; 8888145252, 1832300104, 20884521014241; 8888145252, 1832300105, 20884521014241; 8888145252, 1833100107, 20884521014241; 8888145252, 1833800142, 20884521014241; 8888145252, 1907800085, 20884521014241; 8888145252, 1908400301, 20884521014241; 8888145252, 1913000179, 20884521014241; 8888145252, 1913000180, 20884521014241; 8888145252, 1913000181, 20884521014241; 8888145252, 1914000241, 20884521014241; 8888145252, 1914800206, 20884521014241; 8888145252, 1915800101, 20884521014241; 8888145252, 1917200226, 20884521014241; 8888145252, 1935100108, 20884521014241; 8888145252, 1935100109, 20884521014241; 8888145252, 2002900149, 20884521014241; 8888145252, 2009300077, 20884521014241; 8888145252, 2014900160, 20884521014241; 8888145252, 2015400078, 20884521014241; 8888145252, 2019500174, 20884521014241; 8888145252, 2019500178, 20884521014241; 8888145252, 2019500270, 20884521014241; 8888145252, 2020400103, 20884521014241; 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8888145253, 2102500101, 20884521014272; 8888145253, 2124600200, 20884521014272; 8888145254, 1715800115, 10884521014329; 8888145254, 1716500175, 10884521014329; 8888145254, 1717800131, 10884521014329; 8888145254, 1717900146, 10884521014329; 8888145254, 1718600100, 10884521014329; 8888145254, 1719300096, 10884521014329; 8888145254, 1720500101, 10884521014329; 8888145254, 1833100104, 10884521014329; 8888145254, 1835300224, 10884521014329; 8888145254, 1903500127, 10884521014329; 8888145254, 1917200227, 10884521014329; 8888145254, 2027200201, 10884521014329; 8888145254, 1715800115, 20884521014326; 8888145254, 1716500175, 20884521014326; 8888145254, 1717800131, 20884521014326; 8888145254, 1717900146, 20884521014326; 8888145254, 1718600100, 20884521014326; 8888145254, 1719300096, 20884521014326; 8888145254, 1720500101, 20884521014326; 8888145254, 1720700110, 20884521014326; 8888145254, 1833100104, 20884521014326; 8888145254, 1835300224, 20884521014326; 8888145254, 1903500127, 20884521014326

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1320-2022

Related Recalls

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Jun 23, 2025 Diagnostic Equipment Nationwide View Details →