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FDAFDA · Food and drugs·Recall number Z-1315-2022

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Published July 13, 2022 · Recall initiated: June 8, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Covidien Llc
Distributor
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.
Lot
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, 1088452115817
Risk classification
Class I
Area (FDA)
device
Country
United States

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