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 affected sutures.
- Product’s applicable scope: applicable for suturing and ligation in general soft tissues in cardiovascular, neurosurgical, and ophthalmic procedures.
- Affected recall areas: China, U.S
- Recall quantity in China: 188 boxes
- Corrective actions: Covidien China will send recall notices to all affected customers, explaining the background and requirements of the recall. At the same time, operations and use of the affected products will be immediately halted. Unused affected products should be returned along with signed confirmation letters. After the products are returned, they will be isolated in our warehouse. Based on the final disposal plan, it will decide whether to return them to the original manufacturer or destroy them.
Recall Regulation in China
“Administrative Measures for the Recall of Medical Devices” 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.
The “defective” medical device products have the following scenarios:
- Products with unreasonable risks that may endanger human health/life under normal uses.
- Products that do not meet the technical requirements or mandatory standards.
- Products that do not meet the relevant production and qualify management regulations which may lead to unreasonable risks.
- Other products that need to be recalled
With the implementation of Decree 739, 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 info@ChinaMedDevice.com for recall-related services.
See last quarter’s recall summary HERE
Watch our recorded webinar for “Overview PMS Key Updates – Enhanced Requirements of Post Market Surveillance Per Order 739”
About China Med Device
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.
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.