Le 3 septembre 2026, la soci\u00e9t\u00e9 B. Braun Medical Inc., bas\u00e9e \u00e0 Bethlehem (Pennsylvanie, \u00c9tats-Unis), a annonc\u00e9 un rappel volontaire de trois lots de solution injectable de chlorure de sodium \u00e0 0,9 % (0.9% Sodium Chloride Injection USP, 100 mL, en poche PAB\u00ae de 150 mL). L\u2019annonce est diffus\u00e9e par la Food and Drug Administration (FDA) am\u00e9ricaine, qui pr\u00e9cise qu\u2019il s\u2019agit d\u2019une information de service public. Le rappel concerne le niveau h\u00f4pital\/\u00e9tablissement de sant\u00e9\/utilisateur.<\/p>\n
Le motif du rappel est la pr\u00e9sence de particules dans le produit, identifi\u00e9es comme oxyde de fer, particules inorganiques, cellulose ou polystyr\u00e8ne. Le produit est indiqu\u00e9 chez l\u2019adulte et l\u2019enfant comme source d\u2019\u00e9lectrolytes et d\u2019eau pour l\u2019hydratation, et comme diluant et syst\u00e8me d\u2019administration intermittente pour des m\u00e9dicaments compatibles. Il est conditionn\u00e9 en poches souples sans PVC et sans DEHP.<\/p>\n
Selon l\u2019\u00e9valuation de risque pr\u00e9sent\u00e9e, l\u2019administration intraveineuse d\u2019une solution contenant de telles particules peut entra\u00eener des effets graves et potentiellement mortels : embolie pulmonaire, occlusion d\u2019autres vaisseaux sanguins avec risque de n\u00e9crose tissulaire et de l\u00e9sions d\u2019organe, phl\u00e9bite avec risque de thrombose, activation syst\u00e9mique du syst\u00e8me immunitaire, dysfonction d\u2019organe et h\u00e9molyse. \u00c0 la date de l\u2019annonce, aucun cas de l\u00e9sion grave, de d\u00e9c\u00e8s ou autre effet ind\u00e9sirable li\u00e9 \u00e0 ce probl\u00e8me n\u2019a \u00e9t\u00e9 signal\u00e9.<\/p>\n
Les lots rappel\u00e9s sont identifi\u00e9s par les num\u00e9ros de lot J6B435, J6B444 et J6B457, avec une date de p\u00e9remption au 30 avril 2027, un num\u00e9ro de catalogue S8004-5264 et un NDC 0264-1800. Les produits ont \u00e9t\u00e9 distribu\u00e9s \u00e0 l\u2019\u00e9chelle nationale aux \u00c9tats-Unis \u00e0 des h\u00f4pitaux et \u00e9tablissements de sant\u00e9 entre le 27 f\u00e9vrier 2026 et le 3 ao\u00fbt 2026.<\/p>\n
B. Braun informe ses distributeurs et clients par courrier et organise le retour et le remplacement de tous les produits concern\u00e9s. Les clients en possession de ces lots doivent les retourner au point d\u2019achat. Cette situation illustre un cas de gestion de risque li\u00e9 \u00e0 la qualit\u00e9 pharmaceutique d\u2019un solut\u00e9 de perfusion largement utilis\u00e9 en pratique hospitali\u00e8re et la proc\u00e9dure de rappel coordonn\u00e9e avec l\u2019autorit\u00e9 de r\u00e9gulation am\u00e9ricaine (FDA). (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 3 septembre 2026, la soci\u00e9t\u00e9 B. Braun Medical Inc., bas\u00e9e \u00e0 Bethlehem (Pennsylvanie, \u00c9tats-Unis), a annonc\u00e9 un rappel volontaire de trois lots de solution injectable de chlorure de sodium […]<\/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-17796","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\/17796","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=17796"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17796\/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=17796"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17796"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17796"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}