/ en Mon, 28 Apr 2025 03:07:47 -0500 Thu, 24 Apr 25 15:59:59 -0500 /news/headline/2025-04-24-recall-issued-aspiration-system-qapel-medical <p>The Food and Drug Administration has identified a <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072" target="_blank">Class I recall</a> of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.</p> Thu, 24 Apr 2025 15:59:59 -0500 Recall Management /news/headline/2025-03-21-recall-issued-becton-dickinson-and-company-infusion-pump-adapters <p>The Food and Drug Administration has identified a Class I recall of <a href="https://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris" target="_blank">Becton, Dickinson and Company BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapters</a> due to reports that customers using Systems Manager software who are also connected to the system’s CCE Infusion Adapter may experience delayed system response and backlogging of automated programming requests. Outdated APRs may upload to the Alaris computer, presenting different rate, dose or volume parameters than the current infusion.</p> Fri, 21 Mar 2025 14:44:49 -0500 Recall Management /news/headline/2025-03-19-fda-issues-recall-medtronic-embolization-devices <p>The Food and Drug Administration has identified a Class I recall of <a href="https://www.fda.gov/medical-devices/medical-device-recalls/embolization-device-recall-and-correction-medtronic-removes-unused-027-compatible-pipeline-vantage" target="_blank">Medtronic Neurovascular 027 Compatible Pipeline Vantage Embolization Devices</a> due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures.</p> Wed, 19 Mar 2025 14:56:00 -0500 Recall Management /news/headline/2025-03-05-baxter-recalls-spectrum-infusion-pumps <p>The Food and Drug Administration March 5 <a href="https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-infusion-pump-issue-baxter-healthcare-corporation">announced</a> that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws. The FDA said missing motor mounting screws could lead to insufficient or excessive therapy, interruption in therapy or delay in therapy, which can result in serious adverse health consequences. Baxter has reported one serious injury related to the issue.</p> Wed, 05 Mar 2025 15:21:35 -0600 Recall Management /news/headline/2024-05-17-fda-issues-import-alert-additional-recommendations-against-using-plastic-syringes-made-china <p>The Food and Drug Administration yesterday announced an <a href="https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication">import alert</a> for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes. The alert was issued for Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co. for not meeting device quality system requirements.</p><p>The FDA recommends that users immediately transition away from using plastic syringes produced by those manufacturers, along with <a href="/news/headline/2024-03-20-fda-advises-against-using-plastic-syringes-made-china">those</a> made by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., unless absolutely necessary until users can transition to alternatives. The FDA continues to evaluate other Chinese-made plastic syringes and recommends not using them, if possible. </p> Fri, 17 May 2024 16:04:36 -0500 Recall Management