Covidien Llc recalls Palindrome Precision HSI Chronic Catheter, Sterile, Single U
Recalled Product
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Code Information organized as "Model No., Serial No., GTIN": 8888119369P, 2031800118, 10884521157736; 8888119369P, 1914400127, 20884521157733; 8888119369P, 1914400128, 20884521157733; 8888119369P, 1933700096, 20884521157733; 8888119369P, 1934400105, 20884521157733; 8888119369P, 2001400076, 20884521157733; 8888119369P, 2005600026, 20884521157733; 8888119369P, 2012100180, 20884521157733; 8888119369P, 2012100187, 20884521157733; 8888119369P, 2017500127, 20884521157733; 8888119369P, 2021000082, 20884521157733; 8888119369P, 2026000164, 20884521157733; 8888119369P, 2028200156, 20884521157733; 8888119369P, 2028200165, 20884521157733; 8888119369P, 2028200185, 20884521157733; 8888119369P, 2028200226, 20884521157733; 8888119369P, 2031800118, 20884521157733; 8888119369P, 2104600161, 20884521157733; 8888119369P, 2104600257, 20884521157733; 8888119369P, 2108100059, 20884521157733; 8888119369P, 2116500097, 20884521157733; 8888119369P, 2116500133, 20884521157733; 8888119369P, 2116900110, 20884521157733; 8888119369P, 2119400169, 20884521157733; 8888123409P, 2127200429, 10884521157804; 8888123409P, 1933000049, 20884521157801; 8888123409P, 1933000050, 20884521157801; 8888123409P, 1933000051, 20884521157801; 8888123409P, 1933000052, 20884521157801; 8888123409P, 1935100072, 20884521157801; 8888123409P, 2006200068, 20884521157801; 8888123409P, 2026000165, 20884521157801; 8888123409P, 2028200163, 20884521157801; 8888123409P, 2028200186, 20884521157801; 8888123409P, 2102800056, 20884521157801; 8888123409P, 2104600163, 20884521157801; 8888123409P, 2115800092, 20884521157801; 8888123409P, 2116900111, 20884521157801; 8888123409P, 2127200429, 20884521157801; 8888128459P, 2002900118, 20884521157870; 8888128459P, 2006200067, 20884521157870; 8888128459P, 2014900161, 20884521157870; 8888128459P, 2115800060, 20884521157870; 8888133509P, 2000700058, 20884521157948; 8888133509P, 2028200224, 20884521157948; 8888145048CP, 2031800121, 10884521158146; 8888145048CP, 1929500065, 20884521158143; 8888145048CP, 2020400100, 20884521158143; 8888145048CP, 2020400101, 20884521158143; 8888145048CP, 2031800121, 20884521158143; 8888145048P, 1916500092, 10884521158153; 8888145048P, 1916500093, 10884521158153; 8888145048P, 2005200100, 10884521158153; 8888145048P, 2005200101, 10884521158153; 8888145048P, 2021000083, 10884521158153; 8888145048P, 2023400068, 10884521158153; 8888145048P, 2026000170, 10884521158153; 8888145048P, 2028200154, 10884521158153; 8888145048P, 2028200157, 10884521158153; 8888145048P, 2028200171, 10884521158153; 8888145048P, 2031800122, 10884521158153; 8888145048P, 2031800124, 10884521158153; 8888145048P, 2115800089, 10884521158153; 8888145048P, 2115800090, 10884521158153; 8888145048P, 2115800091, 10884521158153; 8888145048P, 2115800094, 10884521158153; 8888145048P, 2124500092, 10884521158153; 8888145048P, 2124500102, 10884521158153; 8888145048P, 2124600213, 10884521158153; 8888145048P, 2124600214, 10884521158153; 8888145048P, 1916500092, 20884521158150; 8888145048P, 1916500093, 20884521158150; 8888145048P, 2005200100, 20884521158150; 8888145048P, 2005200101, 20884521158150; 8888145048P, 2021000083, 20884521158150; 8888145048P, 2023400068, 20884521158150; 8888145048P, 2026000170, 20884521158150; 8888145048P, 2028200154, 20884521158150; 8888145048P, 2028200157, 20884521158150; 8888145048P, 2028200171, 20884521158150; 8888145048P, 2031800122, 20884521158150; 8888145048P, 2031800124, 20884521158150; 8888145048P, 2115800089, 20884521158150; 8888145048P, 2115800090, 20884521158150; 8888145048P, 2115800091, 20884521158150; 8888145048P, 2115800094, 20884521158150; 8888145048P, 2124500092, 20884521158150; 8888145048P, 2124500102, 20884521158150; 8888145048P, 2124600213, 20884521158150; 8888145048P, 2124600214, 20884521158150; 8888145049CP, 2031800125, 20884521158167; 8888145049P, 1915800104, 10884521158177; 8888145049P, 1915800105, 10884521158177; 8888145049P, 2000700059, 10884521158177; 8888145049P, 2009300137, 10884521158177; 8888145049P, 2028200159, 10884521158177; 8888145049P, 2034400183, 10884521158177; 8888145049P, 1915800104, 20884521158174; 8888145049P, 1915800105, 20884521158174; 8888145049P, 2000700059, 20884521158174; 8888145049P, 2009300137, 20884521158174; 8888145049P, 2028200159, 20884521158174; 8888145049P, 2034400183, 20884521158174; 8888145050P, 1914800222, 10884521158252; 8888145050P, 2000700060, 10884521158252; 8888145050P, 2009400108, 10884521158252; 8888145050P, 1914800222, 20884521158259; 8888145050P, 1915800086, 20884521158259; 8888145050P, 2000700060, 20884521158259; 8888145050P, 2009400108, 20884521158259; 8888145057CP, 2020400102, 10884521158269; 8888145057CP, 1929500066, 20884521158266; 8888145057CP, 2020400102, 20884521158266; 8888145057P, 1914800224, 10884521158276; 8888145057P, 1914800225, 10884521158276; 8888145057P, 1915800088, 10884521158276; 8888145057P, 1934400103, 10884521158276; 8888145057P, 1934400104, 10884521158276; 8888145057P, 2014900175, 10884521158276; 8888145057P, 2017500129, 10884521158276; 8888145057P, 2019500256, 10884521158276; 8888145057P, 2019500257, 10884521158276; 8888145057P, 2104600232, 10884521158276; 8888145057P, 2110900109, 10884521158276; 8888145057P, 2116500161, 10884521158276; 8888145057P, 2116900114, 10884521158276; 8888145057P, 2124500090, 10884521158276; 8888145057P, 2124600207, 10884521158276; 8888145057P, 2124600235, 10884521158276; 8888145057P, 1914800223, 20884521158273; 8888145057P, 1914800224, 20884521158273; 8888145057P, 1914800225, 20884521158273; 8888145057P, 1934400103, 20884521158273; 8888145057P, 1934400104, 20884521158273; 8888145057P, 2009200091, 20884521158273; 8888145057P, 2014900163, 20884521158273; 8888145057P, 2014900175, 20884521158273; 8888145057P, 2017500129, 20884521158273; 8888145057P, 2019500256, 20884521158273; 8888145057P, 2019500257, 20884521158273; 8888145057P, 2028200172, 20884521158273; 8888145057P, 2104600205, 20884521158273; 8888145057P, 2104600232, 20884521158273; 8888145057P, 2106900155, 20884521158273; 8888145057P, 2110900109, 20884521158273; 8888145057P, 2116500161, 20884521158273; 8888145057P, 2116900114, 20884521158273; 8888145057P, 2124500090, 20884521158273; 8888145057P, 2124600207, 20884521158273; 8888145057P, 2124600235, 20884521158273
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