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Recall Observatory FDA recall evidence

Device product

Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Z-1313-2022

June 08, 2022

Class I

Product summary

Firm
Covidien Llc
Event
Event 90311
Status
Ongoing
Classification
Class I
Quantity
26,675 units
Official record key
device-enforcement:Z-1313-2022

Official wording

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.

Code information: Code Information organized as "Model No., Serial No., GTIN": 8888119365P, 2119400168, 10884521157712; 8888119365P, 1923400245, 20884521157719; 8888119365P, 1923400268, 20884521157719; 8888119365P, 1935100114, 20884521157719; 8888119365P, 2002100145, 20884521157719; 8888119365P, 2002900148, 20884521157719; 8888119365P, 2020400090, 20884521157719; 8888119365P, 2023300173, 20884521157719; 8888119365P, 2026000162, 20884521157719; 8888119365P, 2031800126, 20884521157719; 8888119365P, 2034400186, 20884521157719; 8888119365P, 2104600103, 20884521157719; 8888119365P, 2104600233, 20884521157719; 8888119365P, 2108100057, 20884521157719; 8888119365P, 2116500094, 20884521157719; 8888119365P, 2116500095, 20884521157719; 8888119365P, 2119400168, 20884521157719; 8888119371P, 1935100115, 10884521157750; 8888123405P, 2002100146, 10884521157781; 8888123405P, 2014900155, 10884521157781; 8888123405P, 2104600162, 10884521157781; 8888123405P, 1924000136, 20884521157788; 8888123405P, 1924000157, 20884521157788; 8888123405P, 1927300064, 20884521157788; 8888123405P, 1928800238, 20884521157788; 8888123405P, 2002100146, 20884521157788; 8888123405P, 2014900155, 20884521157788; 8888123405P, 2023300174, 20884521157788; 8888123405P, 2026000173, 20884521157788; 8888123405P, 2028200162, 20884521157788; 8888123405P, 2104600162, 20884521157788; 8888123405P, 2106900134, 20884521157788; 8888123405P, 2115800062, 20884521157788; 8888123405P, 2115800093, 20884521157788; 8888123405P, 2119400133, 20884521157788; 8888123411P, 2119400128, 20884521157825; 8888128455P, 2002100148, 10884521157859; 8888128455P, 1924000181, 20884521157856; 8888128455P, 1927300066, 20884521157856; 8888128455P, 2002100148, 20884521157856; 8888128455P, 2104600164, 20884521157856; 8888128455P, 2127200433, 20884521157856; 8888128461P, 2012100186, 20884521157894; 8888133505P, 1924600127, 20884521157924; 8888145043CP, 1927500054, 10884521158061; 8888145043CP, 2021000087, 10884521158061; 8888145043CP, 2026000094, 10884521158061; 8888145043CP, 2026000166, 10884521158061; 8888145043CP, 2120000069, 10884521158061; 8888145043CP, 1927500053, 20884521158068; 8888145043CP, 1927500054, 20884521158068; 8888145043CP, 2021000087, 20884521158068; 8888145043CP, 2026000093, 20884521158068; 8888145043CP, 2026000094, 20884521158068; 8888145043CP, 2026000166, 20884521158068; 8888145043CP, 2028200155, 20884521158068; 8888145043CP, 2115800061, 20884521158068; 8888145043CP, 2120000069, 20884521158068; 8888145043P, 1917200199, 10884521158078; 8888145043P, 1917200200, 10884521158078; 8888145043P, 1917200201, 10884521158078; 8888145043P, 1917200280, 10884521158078; 8888145043P, 1917200281, 10884521158078; 8888145043P, 1917600109, 10884521158078; 8888145043P, 1917600110, 10884521158078; 8888145043P, 2028200184, 10884521158078; 8888145043P, 2028200227, 10884521158078; 8888145043P, 1917200199, 20884521158075; 8888145043P, 1917200200, 20884521158075; 8888145043P, 1917200201, 20884521158075; 8888145043P, 1917200280, 20884521158075; 8888145043P, 1917200281, 20884521158075; 8888145043P, 1917600109, 20884521158075; 8888145043P, 1917600110, 20884521158075; 8888145043P, 1921300033, 20884521158075; 8888145043P, 1921900180, 20884521158075; 8888145043P, 2028200184, 20884521158075; 8888145043P, 2028200227, 20884521158075; 8888145044CP, 1907800083, 10884521158085; 8888145044CP, 1927500061, 10884521158085; 8888145044CP, 1927500062, 10884521158085; 8888145044CP, 2023300154, 10884521158085; 8888145044CP, 2026000123, 10884521158085; 8888145044CP, 2026000124, 10884521158085; 8888145044CP, 2026000125, 10884521158085; 8888145044CP, 2026000169, 10884521158085; 8888145044CP, 2119400129, 10884521158085; 8888145044CP, 2119400144, 10884521158085; 8888145044CP, 2125800093, 10884521158085; 8888145044CP, 1907800083, 20884521158082; 8888145044CP, 1927500061, 20884521158082; 8888145044CP, 1927500062, 20884521158082; 8888145044CP, 1929400083, 20884521158082; 8888145044CP, 2014900162, 20884521158082; 8888145044CP, 2023300154, 20884521158082; 8888145044CP, 2026000123, 20884521158082; 8888145044CP, 2026000124, 20884521158082; 8888145044CP, 2026000125, 20884521158082; 8888145044CP, 2026000132, 20884521158082; 8888145044CP, 2026000169, 20884521158082; 8888145044CP, 2119400129, 20884521158082; 8888145044CP, 2119400144, 20884521158082; 8888145044CP, 2125800093, 20884521158082; 8888145044P, 1917600112, 10884521158092; 8888145044P, 1917600113, 10884521158092; 8888145044P, 1917600114, 10884521158092; 8888145044P, 1917600115, 10884521158092; 8888145044P, 1917600135, 10884521158092; 8888145044P, 2023300137, 10884521158092; 8888145044P, 2026000174, 10884521158092; 8888145044P, 2028200164, 10884521158092; 8888145044P, 2028200187, 10884521158092; 8888145044P, 2106900214, 10884521158092; 8888145044P, 2106900227, 10884521158092; 8888145044P, 2124500093, 10884521158092; 8888145044P, 1917600112, 20884521158099; 8888145044P, 1917600113, 20884521158099; 8888145044P, 1917600114, 20884521158099; 8888145044P, 1917600115, 20884521158099; 8888145044P, 1917600135, 20884521158099; 8888145044P, 2023300137, 20884521158099; 8888145044P, 2026000174, 20884521158099; 8888145044P, 2028200164, 20884521158099; 8888145044P, 2028200187, 20884521158099; 8888145044P, 2106900214, 20884521158099; 8888145044P, 2106900227, 20884521158099; 8888145044P, 2124500093, 20884521158099; 8888145045CP, 1929400084, 10884521158108; 8888145045CP, 1929400085, 10884521158108; 8888145045CP, 2026000133, 10884521158108; 8888145045CP, 1929400084, 20884521158105; 8888145045CP, 1929400085, 20884521158105; 8888145045CP, 2026000133, 20884521158105; 8888145045CP, 2028200166, 20884521158105; 8888145045CP, 2119400136, 20884521158105; 8888145045CP, 2119400195, 20884521158105; 8888145045P, 1917200197, 10884521158115; 8888145045P, 1917200198, 10884521158115; 8888145045P, 2028200169, 10884521158115; 8888145045P, 2115800087, 10884521158115; 8888145045P, 2115800088, 10884521158115; 8888145045P, 1917200197, 20884521158112; 8888145045P, 1917200198, 20884521158112; 8888145045P, 2028200169, 20884521158112; 8888145045P, 2115800087, 20884521158112; 8888145045P, 2115800088, 20884521158112; 8888145046CP, 1924600100, 10884521158122; 8888145046CP, 1924600100, 20884521158129; 8888145046CP, 1926100280, 20884521158129; 8888145046CP, 1926800384, 20884521158129; 8888145046CP, 1929400094, 20884521158129; 8888145046CP, 2026000139, 20884521158129; 8888145046CP, 2028200167, 20884521158129; 8888145046P, 1916500094, 10884521158139; 8888145046P, 1916500095, 10884521158139; 8888145046P, 1920500226, 10884521158139; 8888145046P, 1921300030, 10884521158139; 8888145046P, 1916500094, 20884521158136; 8888145046P, 1916500095, 20884521158136; 8888145046P, 1921300030, 20884521158136; 8888145068P, 1934400183, 20884521158426; 8888145069P, 2104600231, 20884521158433; 8888145070P, 2026000172, 20884521158440; 8888145071P, 1922100139, 20884521158457

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.