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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1312-2022

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

Publicado el 13 de julio de 2022 · Inicio del retiro: 8 de junio de 2022

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Covidien Llc
Distribuidor
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.
Lote
Code Information organized as "Model No., Serial No., GTIN": 8888123400, 1729700111, 20884521012933; 8888123400, 1831000130, 20884521012933; 8888123400, 1904600085, 20884521012933; 8888133500, 2012100128, 20884521013060; 8888119360P, 2007800129, 10884521157699; 8888119360P, 2034400078, 10884521157699; 8888119360P, 1720000102, 20884521157696; 8888119360P, 1904200103, 20884521157696; 8888119360P, 1923400228, 20884521157696; 8888119360P, 1932300203, 20884521157696; 8888119360P, 2007800129, 20884521157696; 8888119360P, 2034400078, 20884521157696; 8888119360P, 2104600179, 20884521157696; 8888119360P, 2110900110, 20884521157696; 8888119360P, 2113300438, 20884521157696; 8888119360P, 2127700068, 20884521157696; 8888119364P, 1925200093, 10884521157705; 8888119364P, 1934400186, 10884521157705; 8888119364P, 2019500171, 10884521157705; 8888119364P, 2020400088, 10884521157705; 8888119364P, 2028200217, 10884521157705; 8888119364P, 2034400079, 10884521157705; 8888119364P, 2034400115, 10884521157705; 8888119364P, 2034400123, 10884521157705; 8888119364P, 2104600111, 10884521157705; 8888119364P, 2119300075, 10884521157705; 8888119364P, 2119700074, 10884521157705; 8888119364P, 1832300117, 20884521157702; 8888119364P, 1914800155, 20884521157702; 8888119364P, 1914800159, 20884521157702; 8888119364P, 1914800160, 20884521157702; 8888119364P, 1917200272, 20884521157702; 8888119364P, 1921300039, 20884521157702; 8888119364P, 1921300040, 20884521157702; 8888119364P, 1925200092, 20884521157702; 8888119364P, 1925200093, 20884521157702; 8888119364P, 1927300069, 20884521157702; 8888119364P, 1934400185, 20884521157702; 8888119364P, 1934400186, 20884521157702; 8888119364P, 2001400079, 20884521157702; 8888119364P, 2002100127, 20884521157702; 8888119364P, 2003100105, 20884521157702; 8888119364P, 2003100106, 20884521157702; 8888119364P, 2003100107, 20884521157702; 8888119364P, 2019500171, 20884521157702; 8888119364P, 2020400088, 20884521157702; 8888119364P, 2020400089, 20884521157702; 8888119364P, 2023300159, 20884521157702; 8888119364P, 2027200226, 20884521157702; 8888119364P, 2028200217, 20884521157702; 8888119364P, 2031800142, 20884521157702; 8888119364P, 2034400079, 20884521157702; 8888119364P, 2034400087, 20884521157702; 8888119364P, 2034400115, 20884521157702; 8888119364P, 2034400123, 20884521157702; 8888119364P, 2104600111, 20884521157702; 8888119364P, 2104600167, 20884521157702; 8888119364P, 2104600237, 20884521157702; 8888119364P, 2106900097, 20884521157702; 8888119364P, 2110900095, 20884521157702; 8888119364P, 2113300439, 20884521157702; 8888119364P, 2119300075, 20884521157702; 8888119364P, 2119700074, 20884521157702; 8888119364P, 2119700083, 20884521157702; 8888119364P, 2119700093, 20884521157702; 8888119364P, 2119700104, 20884521157702; 8888119364P, 2127200412, 20884521157702; 8888119370P, 1814300198, 20884521157740; 8888119370P, 1915800108, 20884521157740; 8888119370P, 2019500268, 20884521157740; 8888119370P, 2034400116, 20884521157740; 8888123400P, 1825400108, 20884521157764; 8888123400P, 1831600198, 20884521157764; 8888123400P, 1917200273, 20884521157764; 8888123400P, 1923400230, 20884521157764; 8888123400P, 2002100128, 20884521157764; 8888123400P, 2009300079, 20884521157764; 8888123400P, 2026000063, 20884521157764; 8888123400P, 2034400105, 20884521157764; 8888123400P, 2104600243, 20884521157764; 8888123400P, 2106900108, 20884521157764; 8888123400P, 2113400073, 20884521157764; 8888123400P, 2119700079, 20884521157764; 8888123400P, 2119700098, 20884521157764; 8888123404P, 2002100129, 10884521157774; 8888123404P, 2009300026, 10884521157774; 8888123404P, 2023300162, 10884521157774; 8888123404P, 2034400117, 10884521157774; 8888123404P, 2034400147, 10884521157774; 8888123404P, 2104600180, 10884521157774; 8888123404P, 2104600244, 10884521157774; 8888123404P, 2106900116, 10884521157774; 8888123404P, 2119300074, 10884521157774; 8888123404P, 2119700076, 10884521157774; 8888123404P, 2119700105, 10884521157774; 8888123404P, 2203800225, 10884521157774; 8888123
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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