Medical network, June 22, total bureau of national food and drug supervision and administration of 21 announcement said the food administration of drug safety organization of disposable endotracheal intubation, medical electronic thermometers and other three varieties 247 group (Taiwan) medical equipment product quality supervision and sampling inspection, found that six group (Taiwan) products do not conform to the prescribed standards.
Project, according to the announcement by sampling is not in conformity with the standards of medical equipment products are: dongguan xiehe medical equipment technology co., LTD. Production of 1 digital electronic thermometer, maximum allowable error is not in conformity with the prescribed standards; Henan yazhong industrial co., LTD., henan jiqi medical equipment co., LTD., a batch of pipe intubation, the bag (full diameter) is not up to standard; Shandong huge pigeon dental materials co., LTD. Has produced a batch of elastomers. The working time is not up to standard.
In addition, treasure source biological technology (Beijing) co., LTD production of 1 medical electronic thermometer, yiwu lark medical equipment co., LTD., one of the electronic thermometer, equipment or equipment parts of external markers do not conform to the prescribed standards.
Announcement, points out that the above does not comply with the standard products, food drug safety administration has asked the enterprise local food and drug supervision and administration authority in accordance with the relevant provisions, to investigate the related enterprises.
Food drug safety administration stressed that related to medical device manufacturing enterprise does not conform to the stipulations of the products, does not conform to the standards set by the standard project risk assessment, according to the severity of the medical equipment defect level of recall, is voluntarily recalling and public recall information. The provincial food and drug supervision and administration department located at the provincial level shall supervise the recall of enterprises, and the recall shall be ordered to be recalled. Provided is not in conformity with the standards of medical equipment products cause harm to human body or there is evidence that may endanger human body health, should be taken to suspend the production, import, management, use of emergency control measures.
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