Les autorit\u00e9s sanitaires am\u00e9ricaines signalent un rappel de dispositifs m\u00e9dicaux jug\u00e9 de type le plus grave par la Food and Drug Administration (FDA), en raison d\u2019un risque de blessure grave ou de d\u00e9c\u00e8s en cas de poursuite de l\u2019utilisation. Le rappel concerne des \u00ab convenience kits \u00bb de la soci\u00e9t\u00e9 Medline contenant certains applicateurs antiseptiques BD ChloraPrep, susceptibles d\u2019\u00eatre contamin\u00e9s par le champignon Aspergillus penicillioides dans certaines conditions environnementales.<\/p>\n
Les dispositifs concern\u00e9s sont des kits Medline int\u00e9grant notamment les produits BD ChloraPrep suivants : ChloraPrep Clear applicateur st\u00e9rile 1 mL (num\u00e9ro d\u2019article 930480, lot 4032183) et FREPP Clear applicateur 1,5 mL avec opercule papier (num\u00e9ro d\u2019article 930299, lot 4073005). Une liste compl\u00e8te des produits affect\u00e9s est annonc\u00e9e comme disponible mais n\u2019est pas d\u00e9taill\u00e9e dans le texte.<\/p>\n
La FDA indique \u00eatre inform\u00e9e qu\u2019une lettre a \u00e9t\u00e9 adress\u00e9e par Medline le 11 ao\u00fbt \u00e0 tous les clients concern\u00e9s, leur demandant de retirer ces kits des lieux d\u2019utilisation ou de vente. Medline demande aux \u00e9tablissements de : v\u00e9rifier imm\u00e9diatement leurs stocks, mettre en quarantaine tous les kits concern\u00e9s, puis d\u00e9truire l\u2019int\u00e9gralit\u00e9 de chaque kit apr\u00e8s avoir rempli les formulaires de r\u00e9ponse. Les distributeurs ou revendeurs doivent informer leurs propres clients, leur demander de d\u00e9truire les produits affect\u00e9s et reporter les quantit\u00e9s de leurs clients dans les formulaires de r\u00e9ponse.<\/p>\n
Cette communication actualise une notification pr\u00e9c\u00e9dente de Medline dat\u00e9e du 12 juin 2026. Initialement, les clients \u00e9taient invit\u00e9s \u00e0 apposer une \u00e9tiquette sur les kits concern\u00e9s afin d\u2019indiquer que seul le composant BD ChloraPrep devait \u00eatre retir\u00e9 et \u00e9limin\u00e9 au moment de l\u2019utilisation. Sur la base d\u2019informations compl\u00e9mentaires fournies ult\u00e9rieurement par BD (Becton, Dickinson and Company) sur ses applicateurs ChloraPrep, Medline modifie d\u00e9sormais les consignes pour certains lots : les clients doivent d\u00e9truire le kit complet. Cette mise \u00e0 jour ne s\u2019applique qu\u2019aux articles list\u00e9s dans la nouvelle communication et ne modifie pas les consignes relatives aux autres kits mentionn\u00e9s dans la notification du 12 juin 2026.<\/p>\n
Les enjeux principaux pour les politiques de sant\u00e9 concernent la gestion des risques li\u00e9s \u00e0 la contamination fongique de dispositifs antiseptiques utilis\u00e9s en contexte de soins, la tra\u00e7abilit\u00e9 des lots concern\u00e9s, la coordination entre fabricant (BD), assembleur de kits (Medline) et autorit\u00e9 de r\u00e9gulation (FDA), ainsi que l\u2019ajustement des mesures de rappel en fonction d\u2019informations nouvelles sur la s\u00e9curit\u00e9 des produits. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Les autorit\u00e9s sanitaires am\u00e9ricaines signalent un rappel de dispositifs m\u00e9dicaux jug\u00e9 de type le plus grave par la Food and Drug Administration (FDA), en raison d\u2019un risque de blessure grave […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-20806","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20806","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20806"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20806\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20806"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20806"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20806"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}