Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Enforcement
- Recall Number
- Z-1313-2022
- Event ID
- 90311
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 13, 2022
- Initiation Date
- June 8, 2022
- Classification Date
- July 7, 2022
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
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 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
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.
26,675 units