Johnson & Johnson, Medtronic and other companies voluntarily recall related products

Johnson & Johnson, Medtronic and other companies voluntarily recall related products

Release date: 2014-12-18

Recently, the State Food and Drug Administration issued four consecutive announcements on the recall of medical device products, including Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., Leidumit Medical Equipment (Shanghai) Co., Ltd., Medtronic (Shanghai) Management Co., Ltd.珂 (Shanghai) Medical Equipment Co., Ltd. 4 companies. The recalled products are: Schanz nail and orthopedic (orthopedic) surgical instruments, disposable human arterial blood sample collectors, disposable infusion lines and needles for insulin pumps, and computer radiography systems. The four recalls were reported to the State Administration by the Shanghai Food and Drug Administration.
Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. reports that metal devices cannot be labeled as "MR Safe" according to current ASTM F2503 testing standards, but certain components of CMF mandibular external fixator systems I and II have been identified or The word "MR Safe" is etched and some changes to the label are required. Synthes GmbH implements a voluntary recall of the products involved. The recall level is Level II.
Leymite Medical Equipment (Shanghai) Co., Ltd. reported that due to the one-time use of the human artery blood sample collector (registration number: National Food and Drug Administration (in) word 2013 No. 3664693), some needles have unidentified brown objects on the surface, Radiometer Medical ApS implements a voluntary recall of the products involved. The recall level is Level II.
Medtronic (Shanghai) Management Co., Ltd. reports that due to the disposable infusion line and needle for insulin pump (registration number: National Food and Drug Administration (into) word 2014 No. 3660314, National Food and Drug Administration (in) word 2012 The report of the hose pull-out connector of No. 3660920) shows an increasing trend, and Unomedical a/s implements a voluntary recall of the products involved. The recall level is Level II.
Ruiyi (Shanghai) Medical Equipment Co., Ltd. reported that the company found that the computerized radiology imaging system (registration number: Shanghai Food and Drug Administration (quasi) word 2011 No. 2310117) uses the V5.7 version of the software and installed the Classic of the mammography component. CR/Elite CR, if the user “multi-format prints” the mammography image, the image will be automatically scaled to the appropriate scale, instead of printing according to the actual size selected by the user. This problem may affect the doctor's comparison of the abnormal image size. Identification (eg microcalcification). Ruiyi (Shanghai) Medical Equipment Co., Ltd. implemented an active recall of the products involved. The recall level is Level II.

Source: China Medical News

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