{"id":506492,"date":"2024-02-04T22:25:06","date_gmt":"2024-02-05T03:25:06","guid":{"rendered":"https:\/\/platohealth.ai\/covidien-recalls-188-nonabsorbable-suture-in-china\/"},"modified":"2024-02-04T22:26:52","modified_gmt":"2024-02-05T03:26:52","slug":"covidien-recalls-188-nonabsorbable-suture-in-china","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/covidien-recalls-188-nonabsorbable-suture-in-china\/","title":{"rendered":"Covidien Recalls 188 Nonabsorbable Suture in China","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the most serious public health hazard.<\/p>\n
\u201cAdministrative Measures for the Recall of Medical Devices\u201d released in February 2017 stipulates that medical device manufacturers conduct recall defective products by warning, inspection, repair, re-labeling, modification, and improvement of IFU, software update, replacement, recovery, destruction, etc. Foreign manufacturer can designate an agent in China to conduct the recall.<\/p>\n
The \u201cdefective\u201d medical device products<\/strong><\/a> have the following scenarios:<\/p>\n With the implementation of <\/em>Decree 739<\/strong><\/em><\/a>, post-market surveillance has drawn more attention, and both domestic and foreign devices that do not meet the standards face a greater risk of recall. Email <\/em>info@ChinaMedDevice.com<\/em><\/a> for recall-related services.<\/em><\/p>\n See last quarter\u2019s recall summary <\/em>HERE<\/strong><\/em><\/a><\/p>\n Watch our <\/em>recorded webinar<\/em><\/a> for \u201cOverview PMS Key Updates \u2013 Enhanced Requirements of Post Market Surveillance Per Order 739\u201d<\/em><\/p>\n About China Med Device<\/p>\n China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.<\/p>\n Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trials, recall information, IVDs draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.<\/p>\n Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the most serious public health hazard. Root cause: the sterilization dosage of a specific batch of non-absorbable nylon sutures exceeds the approved range, which may result in compromised tensile strength of the […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":506495,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/506492"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=506492"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/506492\/revisions"}],"predecessor-version":[{"id":506494,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/506492\/revisions\/506494"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/506495"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=506492"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=506492"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=506492"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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