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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