Chinese quality news in August 21, 2017, the State Food and Drug Administration's official website issued a "national medical quality bulletin (2017 eighteenth, total thirty-sixth)", the medical oxygen concentrator (medical oxygen generator), non noble metal dental casting alloys (including ceramic alloy) and other 3 varieties of 155 batch (Taiwan) product quality supervision the inspection of the announcement, the sampling project all meet the standard requirements of medical products involving 54 medical equipment manufacturing enterprises of the 3 varieties of 135 batch (Taiwan).
According to the announcement, the sampling item does not meet the standard medical device products, involving 9 medical device manufacturers of 3 varieties, 15 batches (units). Concretely as:
(a) medical oxygen concentrator (medical oxygen generator) 3 enterprises of 4 products. Beijing Zhonglian Technology Development Company Limited production of 2 medical molecular sieve oxygen generator, oxygen concentration indicator does not meet the standard requirements; 1 medical oxygen concentrator Jiangsu 1 Taiwan SD series Medical Association of molecular medical science and Technology Co Ltd production screening oxygen machine, Fuzhou Ruikang medical instrument limited company to produce, the influence of back pressure meet the standard requirements.
(two) dental non precious metal casting alloy (including ceramic alloy) 1 enterprises, 1 batches of products. Shanghai medical equipment Limited by Share Ltd dental materials factory produced 1 batches of nickel based cast alloy, corrosion resistance is not up to standard.
(three) a single use of sterile vaginal dilator, 5 enterprises, 10 batches of products. Henan YADU Industrial Co. produced 1 batches of disposable sterile vagina dilator, anti deformation capacity does not meet the standard requirements; Hunan Ping An Yixie technology limited production of 1 batches of disposable sterile vagina dilator, epoxy ethane residue does not meet the standards; Nanchang Fukang medical instrument limited company to produce 2 batches of disposable sterile vagina dilator, anti deformation capacity does not meet the standard requirements, of which 1 batches of structural strength does not meet the standard requirements; Nanchang Kangjie medical health products Limited production of 2 batches of one-time use of sterile vagina dilator, appearance does not meet the standard requirements, of which 1 batches of anti deformation capacity does not meet the standard requirements; Changzhou xiaochunmedical Equipment Co., Ltd. the production of 4 batches of disposable sterile vagina dilator, 2 batches, 2 batches of appearance of ethylene Residue of alkane is not up to standard.
The items being inspected as labels, labels and instructions are not in accordance with the standards stipulated in the medical apparatus and instruments products, involving 5 varieties of 1 medical apparatus and instruments manufacturing enterprises, 5 units:
Medical oxygen concentrator (medical oxygen generator) 5 enterprises of 5 products. Hangzhou Chuangwei Air Separation Technology Co. Ltd., Beijing Guangda juxn Technology Co. Ltd. and Jiangsu Jiang hang Medical Equipment Co. Ltd production of the 1 medical molecular sieve oxygen machine, camet (Changzhou) 1 medical oxygen machine 1 sets of small molecular electronic limited production of sieve oxygenerator, Shanghai nursing medical equipment Co. Ltd production the external label does not meet the standard requirements.
The sampling found the product does not meet the standard, the State Food and drug administration has asked the companies where food and drug supervision and management departments to investigate and deal with the relevant enterprises, and asked the provincial food and drug supervision and management departments timely disposal of the case to the public.