{"id":606026,"date":"2026-09-04T20:58:17","date_gmt":"2026-09-04T20:58:17","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/606026\/"},"modified":"2026-09-04T20:58:17","modified_gmt":"2026-09-04T20:58:17","slug":"fda-early-alert-for-draeger-breathing-circuit","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/606026\/","title":{"rendered":"FDA Early\u00a0Alert for Draeger Breathing Circuit"},"content":{"rendered":"<p>Draeger issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they are used or sold, <a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-recalls-and-early-alerts\/early-alert-breathing-circuit-issue-draeger\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">according to an FDA early alert<\/a>.<\/p>\n<p>According to the FDA, <a href=\"https:\/\/respiratory-therapy.com\/tag\/draeger-medical\/\" data-type=\"post_tag\" data-id=\"4833\" rel=\"nofollow noopener\" target=\"_blank\">Draeger<\/a> is aware of cases in which obvious cracks in the hose of the VentStar Resus Neo were detected by the users prior to use.\u00a0<\/p>\n<p>If a cracked hose is used, the hose may fall off or leak resulting in restricted ventilation or delayed therapy which could lead to desaturation, hypoxia, or patient death, the FDA reports.<\/p>\n<p>The VentStar Resus Neo is a disposable breathing circuit used used in <a href=\"https:\/\/respiratory-therapy.com\/tag\/icu-critical-care\/\" data-type=\"post_tag\" data-id=\"4548\" rel=\"nofollow noopener\" target=\"_blank\">critical care<\/a> and <a href=\"https:\/\/respiratory-therapy.com\/disorders-diseases\/critical-care\/emergency-room\/\" data-type=\"category\" data-id=\"1790\" rel=\"nofollow noopener\" target=\"_blank\">emergency care<\/a> to convey breathing gas from a source to an infant (up to 22 lbs).<\/p>\n<p>As of August 27, Draeger has reported no serious injuries or deaths associated with this issue, according to the FDA.<\/p>\n<p>Affected Devices<\/p>\n<p>FDA Recommendations<\/p>\n<p>Users should review and follow the recommendations below to inspect and remove affected product prior to use.<\/p>\n<p>On September 1, Draeger sent all affected customers a letter recommending the following actions:<\/p>\n<p>Carefully inspect the hoses\u00a0for damages prior to use according to the product\u2019s Instructions for Use (IFU).<\/p>\n<p>Discard products that show cracks\u00a0(Figure 1)\u00a0or have a detached hose\u00a0(Figure 2). You do not need to return them to Draeger.<\/p>\n<p>More information, including product images of affected devices, is available at the <a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-recalls-and-early-alerts\/early-alert-breathing-circuit-issue-draeger\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"Draeger issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they&hellip;\n","protected":false},"author":2,"featured_media":606027,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[274132,274133,135129,274134,163,256311,85,46,135093,127704,274135],"class_list":["post-606026","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-cpr-resuscitation","tag-draeger-medical","tag-emergency-medicine-hospital","tag-fda-news","tag-health","tag-icu-critical-care","tag-il","tag-israel","tag-neonatal-and-preterm-infant-care","tag-product-news","tag-product-recall-correction"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/606026","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=606026"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/606026\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/606027"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=606026"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=606026"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=606026"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}