According to the State Food and Drug Administration, many medical device companies voluntarily recalled their products in July. According to the statistics of OFweek Medical Network, there are 30 companies and 50 products from July 1 to August 2. Make a recall. Among them, Philips recalled the most products, a total of 5 categories, followed by Beckman, a total of 4 categories, the following are all recalled medical device products in July for your reference.
1. Hunan Huafu Medical Device Technology Co., Ltd. actively recalled artificial nasolacrimal duct
Hunan Huafu Medical Device Technology Co., Ltd. reported that due to the failure of the product packaging label and instructions to update the production license number, etc., Hunan Huafu Medical Device Technology Co., Ltd. produced artificial nasolacrimal duct (Registration No.: Xiangfu Note 20172660081) Proactive recall. The recall level is three.
2.Instrumentation Laboratory Co. Proactive recall of the XII factor test kit (coagulation method)
Wolfen Medical Devices (Beijing) Co., Ltd. reported that due to the internal identification of the XII factor detection kit (product number 0020011200), the affected batch did not meet the declared airborne stability in the ACL Top family instrument, ie 15 24 hours at °C; available data support the reason for the on-board stability of the XII factor test kit on the instrument for 2 hours, Instrumentation Laboratory Co. The XII factor detection kit (coagulation method) (registration or record number: National Machinery injection into 20162404775) for its production is actively recalled. The recall level is three.
3. Beijing Shimadzu Medical Devices Co., Ltd. took the initiative to recall X-ray photography system
Beijing Shimadzu Medical Devices Co., Ltd. reported that due to the expected service life of the ball support parts on the machine for 10 years, when the equipment is used for more than 10 years or in abnormal use, the fixed shaft of the ball support part (CH-200) There are very few parts that may cause cracks. If the cracks continue to increase, the tube support shaft may break, causing the support of the tube to tilt. Beijing Xingjin Medical Devices Co., Ltd. produces X-ray system (registered or Record number: National Food and Drug Administration (quasi) (2008 No. 3301062) voluntary recall.
4.Microline Surgical, Inc. Active recall of laparoscopic surgical instruments
Beijing Weini Huili Medical Devices Co., Ltd. reported that there is potential for cracking after autoclaving/resterilization due to the insulation layer made of black heat-shrinkable material on ReNew repeating operation head (gripper and separating pliers). Risk reasons, Microline Surgical, Inc. The laparoscopic surgical instruments (registration or record number: National Food and Drug Administration (Jin) No. 2014 No. 3220762) were actively recalled. The recall level is three.
5.Cordis Cashel proactive recall of the abdominal aortic aneurysm stent system
Contith (Shanghai) Medical Devices Co., Ltd. reported that it was mistakenly sent to three hospitals in Italy and Switzerland because the company's abdominal aortic aneurysm stent system was produced at five new production sites but has not yet received new CE certification. The manufacturer, Cordis Cashel, voluntarily recalled the abdominal aortic aneurysm stent system (Registration No.: National Machinery Note 20163460340). The recall level is three.
6. Philips X-ray computed tomography apparatus voluntarily recalled
Philips (China) Investment Co., Ltd. reported that due to the failure of the torque wrench calibration test by the company's X-ray computed tomography equipment, the X-ray tube installation fastener torque error may occur, the manufacturer Philips Medical Systems (Cleveland), Inc. . The X-ray computed tomography equipment (Registration No.: National Machinery Note 20153302507) produced by it was voluntarily recalled. The recall level is three.
7. Ossendo Medical Devices Trading (China) Co., Ltd. actively recalls phenytoin determination dry film (immune rate method)
Orson Medical Devices Trading (China) Co., Ltd. reports that product testing for citrate plasma samples may be negatively biased. Orson Medical Devices Trading (China) Co., Ltd. took the initiative to recall the phenytoin determination dry film (immune rate method) (registration number: National Machinery Note 20152402811). The recall level is Level 2.
8. Bole Life Medical Products (Shanghai) Co., Ltd. actively recalls lotion and diluent
Bole Life Medical Products (Shanghai) Co., Ltd. reported that there was an error in the Chinese label of the product. Bole Life Medical Products (Shanghai) Co., Ltd. took the initiative to recall the lotion and diluent (Registration No.: National Food and Drug Administration (Jin) No. 2014 No. 1400605). The recall level is three.
9. Roche Diagnostics (Shanghai) Co., Ltd. actively recalls glucose, lactic acid and urea electrode cartridges
Roche Diagnostics (Shanghai) Co., Ltd. reports that product software issues may affect urea test results. Roche Diagnostics (Shanghai) Co., Ltd. took the initiative to recall the glucose, lactic acid, and urea electrode cartridges (Registration No.: National Food and Drug Administration (Jin) No. 2014 No. 2403745). The recall level is Level 2.
10. Beckman Coulter Trading (China) Co., Ltd. voluntarily recalls a number of biochemical calibrators
Beckman Coulter Trading (China) Co., Ltd. reported that there may be a negative bias in the sodium ion recovery value of the product. Beckman Coulter Trading (China) Co., Ltd. took the initiative to recall a number of biochemical calibrators (Registration No.: National Machinery Note 20152401835). The recall level is three.
11. Platinum Elmer Medical Diagnostics (Shanghai) Co., Ltd. actively recalls 17α-hydroxyprogesterone assay kit (time-resolved fluorescence method)
Platinum Elmer Medical Diagnostics (Shanghai) Co., Ltd. reports that the product component label is incorrect. Platinum Elmer Medical Diagnostics (Shanghai) Co., Ltd. actively recalls the 17α-hydroxyprogesterone assay kit (time-resolved fluorescence method) (Registration No.: National Machinery Note 20153402061). The recall level is three.
12. Dräger Medical Equipment (Shanghai) Co., Ltd. actively recalls patient monitors
Dräger Medical Devices (Shanghai) Co., Ltd. reported that the product memory module may cause the monitor to malfunction. Dräger Medical Equipment (Shanghai) Co., Ltd. took the initiative to recall the patient monitor (registration number: National Machinery Note 20163210771). The recall level is Level 2.
13. Contith (Shanghai) Medical Devices Co., Ltd. actively recalls the pressure pump
Contith (Shanghai) Medical Devices Co., Ltd. reported that the plastic box inside the product may be damaged. Contith (Shanghai) Medical Devices Co., Ltd. took the initiative to recall the pressure pump (Registration No.: National Machinery Injection No. 20153662367). The recall level is Level 2.
14. Mérieux Diagnostics (Shanghai) Co., Ltd. actively recalls the free thyroxine assay kit (enzyme-linked fluorescence method)
Mérieux Diagnostics (Shanghai) Co., Ltd. reported that the relative fluorescence value of the product test was low, resulting in abnormal test results. Mérieux Diagnostics (Shanghai) Co., Ltd. voluntarily recalled the free thyroxine assay kit (enzyme-linked fluorescence method) (Registration No.: National Food and Drug Administration (Jin) No. 2014 No. 2403542). The recall level is Level 2.
15.Mérieux Diagnostics (Shanghai) Co., Ltd. actively recalls products such as Gram-negative bacteria identification cards
Mérieux Diagnostics (Shanghai) Co., Ltd. reported that the package contained in the product part was damaged. Mérieux Diagnostics (Shanghai) Co., Ltd. Gram-negative Bacterial Identification Card, Gram-positive Bacterial Identification Card, Yeast Identification Card, Haemophilus Neisseria Identification Card, Gram-negative Bacterial Drug Sensitive Card, Leather Lan's positive bacteria drug sensitive card, Streptococcus pneumoniae drug sensitive card, Gram-negative bacteria drug sensitive card (registration number: National Machinery into 20162404836; National Machinery into 20162402447; National Machinery into 20162404809; National Machinery into 20152400350; National Machinery into 20152403280 ; National Machinery into 20162400856; National Machinery into 20152404070; National Machinery into 20162400873; National Food and Drug Administration (in) word 2014 No. 2401436; National Food and Drug Administration (into) word 2014 No. 2403914; National Machinery into 20152403735; Machinery into 20152403734; National Machinery into 20162405205; National Machinery into 20162405211;) voluntary recall. The recall level is Level 2.
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