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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3137-2017

Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

Publicado el 27 de septiembre de 2017 · Inicio del retiro: 13 de julio de 2017

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

Qué peligro representa

Stylette removal difficulties on the Euphora and Solarice products.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Vascular Galway DBA Medtronic Ireland
Distribuidor
Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KOREA, LATVIA, LEBANON, LIECHTENSTEIN, LITHUANIA, MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PAPUA NEW GUINEA, PHILIPPINES, POLAND, PORTUGAL, REUNION, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VIET NAM
Lote
Product Number / CFN GTIN Lot SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388 SLC2520X 00643169680227 212621130 SLC4015X 00643169680531 212610378 SLC27520X 00643169680289 212621127 SLC27515X 00643169680272 212621128 SLC3515X 00643169680432 212621129 SLC3020X 00643169680340 212663250 SLC22510X 00643169680135 212671839 SLC3010X 00643169680319 212663249 SLC22506X 00643169680128 212671834 SLC2506X 00643169680180 212671836 SLC2025X 00643169680104 212671880 SLC37515X 00643169680487 212671833 SLC32515X 00643169680388 212671838 SLC4010X 00643169680517 212671837 SLC22520X 00643169680166 212663251 SLC3006X 00643169680302 212671835 SLC2020X 00643169680098 212691165 SLC2512X 00643169680203 212691118 SLC2515X 00643169680210 212691164 SLC2015X 00643169680081 212691160 SLC22512X 00643169680142 212691163 SLC2025X 00643169680104 212691167 SLC2020X 00643169680098 212702017 SLC2530X 00643169680241 212691173 SLC1512X 00643169680029 212691119 SLC2515X 00643169680210 212702018 SLC2015X 00643169680081 212702463 SLC2012X 00643169680074 212710905 SLC2030X 00643169680111 212710910 SLC2510X 00643169680197 212710908 SLC2512X 00643169680203 212702020 SLC2520X 00643169680227 212702019 SLC22520X 00643169680166 212702021 SLC2015X 00643169680081 212702016 SLC3030X 00643169680364 212691171 SLC2020X 00643169680098 212702465 SLC2012X 00643169680074 212709027 SLC2015X 00643169680081 212709026 SLC1520X 00643169680043 212702462 SLC2525X 00643169680234 212691168 SLC22525X 00643169680173 212691166 SLC2012X 00643169680074 212709723 SLC1512X 00643169680029 212702464 SLC2515X 00643169680210 212709726 SLC2512X 00643169680203 212709724 SLC3020X 00643169680340 212710906 SLC1510X 00643169680012 212710907 SLC1515X 00643169680036 212709725 SLC1520X 00643169680043 212709025 SLC4015X 00643169680531 212691162 SLC3512X 00643169680425 212710909 SLC4020X 00643169680548 212691170 SLC27525X 00643169680296 212691172 SLC1512X 00643169680029 212724814 SLC1506X 00643169680005 212724811 SLC1515X 00643169680036 212724813 SLC22515X 00643169680159 212724812 SLC3515X 00643169680432 212691169 SLC1512X 00643169680029 212752474 SLC2020X 00643169680098 212760551 SLC2015X 00643169680081 212760550 SLC2520X 00643169680227 212760552 SLC32512X 00643169680371 212751958 SLC2520X 00643169680227 212751959 SLC2006X 00643169680050 212752340 SLC3520X 00643169680449 212691161 SLC37520X 00643169680494 212751957 SLC2010X 00643169680067 212773513 SLC2015X 00643169680081 212796639 SLC3015X 00643169680333 212796634 SLC2515X 00643169680210 212773514 SLC2515X 00643169680210 212796637 SLC3020X 00643169680340 212796740 SLC2512X 00643169680203 212796633 SLC3510X 00643169680418 212796632 SLC3030X 00643169680364 212796635 SLC2530X 00643169680241 212796638 SLC1520X 00643169680043 212796636 SLC2020X 00643169680098 212796741 SLC2015X 00643169680081 212820860 SLC2515X 00643169680210 212820856 SLC2020X 00643169680098 212820861 SLC2520X 00643169680227 212820857 SLC2012X 00643169680074 212820850 SLC3020X 00643169680340 212820859 SLC3012X 00643169680326 212820853 SLC3010X 00643169680319 212820854 SLC3520X 00643169680449 212820851 SLC37512X 00643169680470 212820847 SLC27515X 00643169680272 212820849 SLC1515X 00643169680036 212820858 SLC2512X 00643169680203 212820852 SLC2020X 00643169680098 212835827 SLC22510X 00643169680135 212835833 SLC2520X 00643169680227 212835823 SLC1515X 00643169680036 212835829 SLC1510X 00643169680012 212835824 SLC2512X 00643169680203 212835832 SLC2012X 00643169680074 212835830 SLC2525X 00643169680234 212835825 SLC3520X 00643169680449 212835828 SLC3010X 00643169680319 212835831 SLC3530X 00643169680463 212835826 SLC4015X 00643169680531 212835822 SLC2515X 00643169680210 212846677 SLC2015X 00643169680081 212855147 SLC27515X 0064
Clasificación de riesgo
Class II
Área (FDA)
device
País
Ireland

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