Les autorit\u00e9s sanitaires am\u00e9ricaines (FDA) signalent un rappel de type le plus s\u00e9rieux (risque de blessure grave ou de d\u00e9c\u00e8s) concernant certains \u00ab convenience kits \u00bb d\u2019Avid Medical contenant des applicateurs BD ChloraPrep potentiellement contamin\u00e9s. La FDA pr\u00e9cise que les produits concern\u00e9s et les recommandations d\u2019utilisation n\u2019ont pas chang\u00e9, mais que l\u2019action \u00e0 mener pour certains lots a \u00e9t\u00e9 durcie.<\/p>\n
Le dispositif concern\u00e9 est un kit IV non st\u00e9rile : \u00ab IV START KIT NON-STERILE, KIT \u00bb, nom de plateau : AVID KIT KRIV26-02, num\u00e9ro de lot 1658437, identifiant unique de dispositif (UDI) 10809160460481. Ces kits peuvent avoir \u00e9t\u00e9 pr\u00e9c\u00e9demment sur-\u00e9tiquet\u00e9s pour signaler le retrait d\u2019un composant au point d\u2019utilisation.<\/p>\n
Le 20 ao\u00fbt, Avid Medical a envoy\u00e9 une nouvelle lettre \u00e0 l\u2019ensemble des clients concern\u00e9s, leur demandant d\u00e9sormais de d\u00e9truire l\u2019int\u00e9gralit\u00e9 des kits concern\u00e9s, et non plus seulement de retirer et jeter le composant incrimin\u00e9. Cette instruction remplace, pour certains produits, une notification ant\u00e9rieure d\u2019Avid Medical dat\u00e9e du 22 juillet 2026, qui pr\u00e9conisait uniquement l\u2019apposition d\u2019un autocollant indiquant le retrait du composant affect\u00e9 avant utilisation. La nouvelle mesure ne s\u2019applique qu\u2019aux articles list\u00e9s dans cette derni\u00e8re communication et ne modifie pas les consignes relatives aux autres kits inclus dans la notification du 22 juillet 2026.<\/p>\n
Les \u00e9tablissements sont invit\u00e9s \u00e0 : v\u00e9rifier imm\u00e9diatement leurs stocks, mettre en quarantaine tous les kits concern\u00e9s, les d\u00e9truire apr\u00e8s remplissage des formulaires de r\u00e9ponse, et, pour les distributeurs ou revendeurs, informer tous les clients finaux et leur demander de d\u00e9truire les produits concern\u00e9s, en reportant les quantit\u00e9s correspondantes dans leur formulaire de retour d\u2019information.<\/p>\n
Le rappel est motiv\u00e9 par un risque de contamination fongique des applicateurs BD ChloraPrep, pouvant favoriser, dans certaines conditions environnementales, la croissance du champignon Aspergillus penicillioides. Avid Medical pr\u00e9cise que cette action s\u2019applique \u00e0 des produits d\u00e9j\u00e0 identifi\u00e9s dans la notification du 22 juillet, mais que les consignes pour certains lots ont \u00e9t\u00e9 modifi\u00e9es \u00e0 la suite d\u2019informations compl\u00e9mentaires transmises par BD (Becton, Dickinson and Company) sur le rappel de ses applicateurs st\u00e9riles ChloraPrep Clear 1 mL Single. Aucun autre \u00e9l\u00e9ment chiffr\u00e9 ni information sur d\u2019\u00e9ventuels cas d\u00e9clar\u00e9s n\u2019est mentionn\u00e9. (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 (FDA) signalent un rappel de type le plus s\u00e9rieux (risque de blessure grave ou de d\u00e9c\u00e8s) concernant certains \u00ab convenience kits \u00bb d\u2019Avid Medical contenant des […]<\/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-20892","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\/20892","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=20892"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20892\/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=20892"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20892"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}