National Bureau of sampling, there are 11 medical devices failed

Nov. 28 hearing Nov. 27, CFDA released the "National Medical Devices Quality Bulletin (No. 26, 2017, No. 44)", there are 11 medical device products do not meet the standard requirements.

This sampling project does not meet standard Specified medical instruments Products, involving eight enterprise The three varieties of 11 batches (Taiwan). Specifically:

Disposable sterile vaginal dilators 5 companies 6 batches of products.

One batch of sterile vaginal dilators produced by Xinxiang Kangmin Edible Material Development Co., Ltd., structural strength, ethylene oxide residues do not meet the standards;

Nanchang Wei Medical Devices Co., Ltd. produced a one-time use of sterile vaginal dilators, the appearance does not meet the standard requirements;

Nanchang Kang Jie Medical Sanitary Products Co., Ltd. produced two batches of disposable sterile vaginal dilators, a batch of anti-deformation ability, 1 batch of ethylene oxide residues do not meet the standard requirements;

Henan Asia Industrial Co., Ltd. produced a batch of disposable sterile vaginal dilator, anti-deformation ability does not meet the standard requirements;

Jiangxi Hongda Medical Devices Group Co., Ltd. produced a one-time use of sterile vaginal dilators, ethylene oxide residues do not meet the standards.

Medical electronic thermometer 1 enterprise 3 products. Xiamen Brothers Technology Co., Ltd. 3 sets of production of medical electronic thermometer, measurement time does not meet the standard requirements.

Medical suture needle (line) 2 2 batches of products. Shanghai warehouse pine Medical Devices Co., Ltd. produced a batch of medical suture needle puncture force does not meet the standard requirements;

1 batch absorbable suture manufactured by Covidien llc 'proxy People: Ke Hui Medical Equipment International Trade (Shanghai) Co., Ltd. ', suture tensile strength does not meet the standard requirements.

The sampling found in the non-compliance with the standard products, the Food and Drug Administration has asked the provincial food and Drug Administration departments where the relevant enterprises to investigate and deal with the supervision of enterprises to conduct product recalls, causes of non-compliance investigation, corrective measures and public disclosure of information Implementation of the situation; products that cause harm to the human body or have evidence that may endanger the human body health They shall, according to law, take emergency control measures of suspending the production, operation and use; and if they need to suspend the importation, they shall promptly make a decision on the administrative decision by the SAIC.