{"id":1292,"date":"2026-01-05T09:00:00","date_gmt":"2026-01-05T10:00:00","guid":{"rendered":"https:\/\/pechealthcare.com\/fda-assigns-class-i-to-ivenix-infusion-set-recall-after-a-misassembly-defect\/"},"modified":"2026-11-09T12:07:03","modified_gmt":"2026-11-09T13:07:03","slug":"fda-assigns-class-i-to-ivenix-infusion-set-recall-after-a-misassembly-defect","status":"publish","type":"post","link":"https:\/\/pechealthcare.com\/fda-assigns-class-i-to-ivenix-infusion-set-recall-after-a-misassembly-defect\/","title":{"rendered":"FDA Assigns Class I to Ivenix Infusion Set Recall After a Misassembly Defect"},"content":{"rendered":"<p>The FDA classified Fresenius Kabi&#8217;s recall of one lot of Ivenix LVP primary administration sets as Class I on January 5, 2026. In the affected lot, the drip chamber and Luer lock are reversed and the downstream tubing is about 24 inches rather than about 72 inches.<\/p>\n<p>The defect can cause reverse flow, drawing fluid from the patient and pushing it back toward the source container. That can lead to unexpected or delayed delivery of fluids, medications or blood products, with the greatest risk to neonates and hemodynamically unstable patients. Reverse flow does not occur with gravity infusion, and no serious injuries or deaths had been reported when the customer letter went out in October 2025.<\/p>\n<p><strong>Why it matters:<\/strong> it is a reminder that consumables, not only pumps, are part of the safety chain, and that incoming inspection of infusion sets is worth the time.<\/p>\n<p><em>Summary written by PEC Healthcare from the original report. Source: <a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-recalls-and-early-alerts\/infusion-pump-recall-fresenius-kabi-removes-ivenix-large-volume-pumps\" target=\"_blank\" rel=\"noopener noreferrer\">U.S. Food and Drug Administration<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A single lot of Ivenix large volume pump administration sets was assembled with the drip chamber and Luer lock reversed, which can cause reverse flow.<\/p>\n","protected":false},"author":1,"featured_media":1328,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1292","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-safety-alert"],"_links":{"self":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/posts\/1292","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/comments?post=1292"}],"version-history":[{"count":1,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/posts\/1292\/revisions"}],"predecessor-version":[{"id":1306,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/posts\/1292\/revisions\/1306"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/media\/1328"}],"wp:attachment":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/media?parent=1292"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/categories?post=1292"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/tags?post=1292"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}