State Food and Drug Administration: Four batches of catheters fail

The State Food and Drug Administration recently released the National Medical Device Quality Announcement No. 4, 2011, which announced the results of quality supervision and inspection of catheter products. Among the 165 batches of catheter products tested, there are four batches of products. The quality is not qualified.

According to the announcement, 113 sampling products involve 113 production enterprises. The unqualified items of four batches of unqualified products mainly involve aseptic and balloon reliability. The four batches of unqualified products were: disposable sterile catheters of 5.3 mm (16Fr-20 ml) in size produced by the Shenshen Shenling Medical Equipment Co., Ltd.; the models produced by Xinxiang Jinshikang Medical Devices Co., Ltd. were double Standard 16# single-use catheterization kit; Hainan Kangyuan Medical Instrument Co., Ltd. produced two-cavity standard type / 14Fr (4.66 mm) 10 ml disposable silicone catheter; Beijing Wandong Coulee medical products The 22Fr (balloon capacity: 30 ml) manufactured by Co., Ltd. is used as a disposable sterile double-lumen catheter.