ExoSeal Vascular Closure Device 의 안전성 경고

Safety alert

2012-11-01

2012-11-01

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121101.html

Medical device safety alert: cordis exoseal vascular closure device medical device manufacturer, cordis corporation (a johnson & johnson company), has issued a field safety notice concerning exoseal vascular closure device. the affected catalogue numbers were ex500ce, ex600ce and ex700ce and affected lot numbers ranged from 15466779 to 15682751. expiration dates of the affected products range from july 2013 through july 2014. cordis recently identified that the affected lots of cordis exoseal vascular closure device were sterilized using a process that did not achieve the sterility assurance level that is required by the standards for this class of product. the discrepancy was detected as part of routine quality control testing. according to manufacturer, no complaints have been reported to date that are related to this issue, and there is no significant increased risk of infection to the patient from exposure to the affected products. therefore, there is no concern for patients who have already been treated with the device and no additional patient follow-up is required. according to the local supplier, johnson & johnson (hk) limited, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 november 2012.