Covidien Llc Recall 90311
Description: Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Covidien Llc Recall 90311 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1315-2022 |
Event ID | 90311 |
Event Description | Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion. |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe. |
Quantity | 25,765 units |
Recall Reason | 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. |
Device Classification | 20220713 |
Device 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 |
Center Classification Date | 20220707 |
Recall Initiation Date | 20220608 |
Recalling Firm | Covidien Llc |
Initial Notification | Letter |
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