Temporary Cardiac Pacing Wires 의 안전성 경고

Safety alert

2012-10-19

2012-10-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019c.html

Medical device safety alert: johnson and johnson temporary cardiac pacing wires medical device manufacturer, johnson & johnson international, has issued a medical device safety alert concerning temporary cardiac pacing wire [product codes.: fep13e and fep15e]. the manufacturer is recalling multiple lots of affected product due to the potential presence of silicone on the blue coating of the stainless steel device. as a precautionary measure, the manufacturer is requesting that users immediately discontinue use of temporary cardiac pacing wire from the following table of product codes and lot numbers: lot number item code dk2ggsp0 fep15e dk2dzzp0 fep15e dk2dpdp0 fep15e dk2ddwp0 fep15e dk2cwmp0 fep13e dk2cmwp0 fep15e dk2cgjp0 fep15e dk2ccgp0 fep13e dk2btlp0 fep13e dk2bddp0 fep13e dj2dpgp0 fep15e 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 product, please contact your supplier for necessary actions. posted on 19 october 2012.