{"id":3874,"date":"2021-09-18T15:42:41","date_gmt":"2021-09-18T07:42:41","guid":{"rendered":"https:\/\/www.cosmomed.com.tw\/?p=3874"},"modified":"2024-07-22T13:05:56","modified_gmt":"2024-07-22T05:05:56","slug":"fda-potential-risk-of-aluminum-leaching-with-use-of-certain-fluid-warmer","status":"publish","type":"post","link":"https:\/\/www.cosmomed.com.tw\/en\/fda-potential-risk-of-aluminum-leaching-with-use-of-certain-fluid-warmer\/","title":{"rendered":"FDA declared recalls of certain Fluid Warmer for Aluminum leaching"},"content":{"rendered":"\n<blockquote class=\"twitter-tweet tw-align-center\"><p dir=\"ltr\" lang=\"en\">Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices \u2013 Letter to Health Care Providers <a href=\"https:\/\/t.co\/EuTSrIggbB\">https:\/\/t.co\/EuTSrIggbB<\/a> <a href=\"https:\/\/t.co\/akEXUx79at\">pic.twitter.com\/akEXUx79at<\/a><\/p>\u2014 US FDA MedWatch (@FDAMedWatch) <a href=\"https:\/\/twitter.com\/FDAMedWatch\/status\/1438201898641895431?ref_src=twsrc%5Etfw\">September 15, 2021<\/a><\/blockquote> <script async=\"\" src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script>\n\n\n\n<p><strong>2021\u5e749\u670815\u65e5\u8a0a<\/strong> \u64da\u7f8e\u570b\u98df\u54c1\u8207\u85e5\u7269\u7ba1\u7406\u5c40(FDA)15\u65e5\u767c\u5e03\u7684\u5b89\u5168\u544a\u8b66<a rel=\"noreferrer noopener\" href=\"https:\/\/public4.pagefreezer.com\/content\/FDA\/21-02-2024T12:58\/https:\/\/www.fda.gov\/medical-devices\/letters-health-care-providers\/potential-risk-aluminum-leaching-use-certain-fluid-warmer-devices-letter-health-care-providers\" target=\"_blank\">[1]<\/a>\u6307\u51fa\u6709\u591a\u5bb6\u5ee0\u5546\u7684\u8f38\u6db2\u3001\u8f38\u8840\u52a0\u6eab\u5668\u56e0\u4f7f\u7528\u542b\u92c1\u52a0\u71b1\u5143\u4ef6\u4e26\u8207\u8f38\u6ce8\u6db2\u76f4\u63a5\u63a5\u89f8\uff0c\u5c0e\u81f4\u52a0\u6eab\u904e\u7a0b\u4e2d\u53ef\u80fd\u6eb6\u89e3\u51fa\u9ad8\u542b\u91cf\u92c1(&gt;25 mcg\/L)\uff0c\u4f7f\u60a3\u8005\u66b4\u9732\u5728\u92c1\u6bd2\u98a8\u96aa\uff0c\u7279\u5225\u662f\u9ad8\u98a8\u96aa\u65cf\u7fa4\u5982\u814e\u529f\u80fd\u8f03\u5dee\u8005\u3001\u65b0\u751f\u5152\u3001\u5b30\u5152\u3001\u5b55\u5a66\u548c\u8001\u5e74\u4eba\uff0c\u8a72\u540d\u55ae\u4e2d\u4e5f\u4e0d\u4e4f\u5168\u7403\u77e5\u540d\u7684\u5feb\u901f\u8f38\u6db2\u7cfb\u7d71\u54c1\u724c\u3002<\/p>\n\n\n\n<p>\u92c1\u6bd2\u53ef\u80fd\u9020\u6210\u7684\u4e0d\u826f\u53cd\u61c9\u5982\u9aa8\u9abc\u75c5\u8b8a\u3001\u8166\u75c5\u8b8a\u3001\u795e\u7d93\u7cfb\u7d71\u50b7\u5bb3\uff0cFDA\u5efa\u8b70\u5404\u91ab\u7642\u6a5f\u69cb\u61c9\u6539\u4f7f\u7528<span style=\"text-decoration: underline;\">\u4e0d\u542b\u92c1\u3001\u4e0d\u540c\u52a0\u71b1\u6a5f\u5236\u7684\u8f38\u6db2\u52a0\u6eab\u5668<\/span>\u4f5c\u70ba\u75c5\u60a3\u9ad4\u6eab\u7ba1\u7406\u7684\u66ff\u4ee3\u65b9\u6848\u3002<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"576\" height=\"576\" src=\"https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg\" alt=\"\" class=\"wp-image-3894\" srcset=\"https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg 576w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-400x400.jpg 400w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-300x300.jpg 300w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-50x50.jpg 50w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-12x12.jpg 12w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-460x460.jpg 460w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-230x230.jpg 230w, https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-160x160.jpg 160w\" sizes=\"(max-width: 576px) 100vw, 576px\" \/><\/figure>\n<\/div>\n\n\n<p><strong>\u53c3\u8003\u8cc7\u6599\uff1a<\/strong><br>[1].<a rel=\"noreferrer noopener\" href=\"https:\/\/public4.pagefreezer.com\/content\/FDA\/21-02-2024T12:58\/https:\/\/www.fda.gov\/medical-devices\/letters-health-care-providers\/potential-risk-aluminum-leaching-use-certain-fluid-warmer-devices-letter-health-care-providers\" target=\"_blank\">Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices &#8211; Letter to Health Care Providers &#8211; U.S. Food &amp; Drug Administration.<\/a><br>[2].<a href=\"https:\/\/www.mdd.gov.hk\/sc\/safety-alerts-communications\/safety-alerts-special-alerts\/archive\/safety-alerts\/important-safety-alerts\/index-id-2142.html\" target=\"_blank\" rel=\"noreferrer noopener\">Important Safety Alerts &#8211; Smiths Medical Level 1 Fast Flow Fluid Warming System and Level 1 NORMOFLO Irrigation System &#8211; \u9999\u6e2f\u885b\u751f\u7f72<\/a><br>[3].<a rel=\"noreferrer noopener\" href=\"https:\/\/healthycanadians.gc.ca\/recall-alert-rappel-avis\/hc-sc\/2021\/76319r-eng.php\" target=\"_blank\">Recalls and safety alerts- LEVEL 1\u00ae Fast Flow and Irrigation Fluid Warming Systems (2021-08-11) &#8211; Government of Canada<\/a><br>[4].<a rel=\"noreferrer noopener\" href=\"https:\/\/www.aboutlawsuits.com\/fluid-warmer-aluminum-recall-188579\/\" target=\"_blank\">FDA Issues Recall, Warning For Certain Fluid Warming Devices Which May Release Too Much Aluminum -AboutLawsuits.com<\/a><br>[5].<a rel=\"noreferrer noopener\" href=\"https:\/\/belmontmedtech.com\/ALUFREE\" target=\"_blank\">Not All Rapid Infusers Are Created Equal &#8211; Belmont Medical Technologies<\/a><br>[6].<a rel=\"noreferrer noopener\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm?id=185975\" target=\"_blank\">Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum &#8211; U.S. Food &amp; Drug Administration.<\/a><br>[7].<a rel=\"noreferrer noopener\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfres\/res.cfm?id=184598\" target=\"_blank\">Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum &#8211; U.S. Food &amp; Drug Administration.<\/a><br>[8].<a rel=\"noreferrer noopener\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRes\/res.cfm?ID=188709\" target=\"_blank\">Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers.<\/a><br>[9].<a rel=\"noreferrer noopener\" href=\"https:\/\/wayback.archive-it.org\/7993\/20201222124155\/https:\/www.fda.gov\/medical-devices\/medical-device-recalls\/vyaire-medical-recalls-enflow-fluid-warming-system-disposable-cartridges-due-potential-risk-exposure\" target=\"_blank\">Vyaire Medical Recalls the enFlow Fluid Warming System Disposable Cartridges Due to Potential Risk of Exposure to Elevated Levels of Aluminum Exposure to Patients<\/a><br>[10].<a rel=\"noreferrer noopener\" href=\"https:\/\/www.facebook.com\/BelmontInst\/photos\/a.327721500716357\/1989859724502518\/\" target=\"_blank\">What&#8217;s in your Fluid Watmer &#8211; Belmont Medical Technologies.<\/a><br>[11].<a rel=\"noreferrer noopener\" href=\"https:\/\/www.facebook.com\/BelmontInst\/photos\/a.327721500716357\/1994684154020075\" target=\"_blank\">Aluminum Toxicity during Fluid Administration &#8211; Belmont Medical Technologies.<\/a> <br>[12].<a rel=\"noreferrer noopener\" href=\"https:\/\/consumer.fda.gov.tw\/Light\/NewsDetail.aspx?nodeID=35&amp;id=5020&amp;rand=623086847\" target=\"_blank\">FDA\u98df\u54c1\u85e5\u7269\u6d88\u8cbb\u8005\u5c08\u5340-\u6d88\u8cbb\u8005\u7d05\u7da0\u71c8<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570bFDA\u767c\u5e03\u5b89\u5168\u544a\u8b66\u6307\u51fa\u591a\u5bb6\u8f38\u6db2\u3001\u8f38\u8840\u52a0\u6eab\u5668\u65bc\u4f7f\u7528\u6642\u6eb6\u89e3\u51fa\u9ad8\u542b\u91cf\u92c1\uff0c\u4f7f\u75c5\u60a3\u66b4\u9732\u5728\u92c1\u6bd2\u98a8\u96aa\uff0c\u5176\u4e2d\u4e0d\u4e4f\u5168\u7403\u77e5\u540d\u7684\u5feb\u901f\u8f38\u6db2\u7cfb\u7d71\u54c1\u724c\u3002<\/p>","protected":false},"author":1,"featured_media":3894,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[65],"tags":[352,66,127,222,94,394,102,95,63],"class_list":["post-3874","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-info","tag-belmont-medical","tag-belmont-rapid-infuser","tag-cosmo-medical","tag-fms2000","tag-ri-2","tag-394","tag-102","tag-95","tag-63"],"jetpack_featured_media_url":"https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg","jetpack_shortlink":"https:\/\/wp.me\/paJTt6-10u","rttpg_featured_image_url":{"full":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"landscape":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"portraits":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"thumbnail":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-300x300.jpg",300,300,true],"medium":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-400x400.jpg",400,400,true],"large":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"1536x1536":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"2048x2048":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"trp-custom-language-flag":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-12x12.jpg",12,12,true],"hestia-blog":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-360x240.jpg",360,240,true],"woocommerce_thumbnail_2x":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-460x460.jpg",460,460,true],"woocommerce_thumbnail":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-230x230.jpg",230,230,true],"woocommerce_single":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2.jpg",576,576,false],"woocommerce_gallery_thumbnail":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/09\/ri-2-aluminum-freev2-160x160.jpg",160,160,true]},"rttpg_author":{"display_name":"pohsun","author_link":"https:\/\/www.cosmomed.com.tw\/en\/author\/pohsun\/"},"rttpg_comment":0,"rttpg_category":"<a 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