Hickman and Leonard Central Venous Catheter kits 의 안전성 경고

Safety alert

2016-04-07

2016-04-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160407.html

Medical device safety alert: bard hickman and leonard central venous catheter kits medical device manufacturer, bard access systems, inc., has issued a medical device safety alert concerning its hickman and leonard central venous catheter kits. the affected product code numbers are as follows: code numbers: 1) 0600560 ; 2) 0600564; 3) 0600580; 4) 0600600; 5) 0600604; 6) 0600620; 7) 0600630; 8) 0600634; 9) 0600650; 10) 0600654; 11) 0606560; 12) 0606564 the manufacturer became aware that an incorrect expiration period was assigned for the introducer needle of three lots included in various central venous catheter products (hickman and leonard catheters). a 15 year expiration period was assigned to the needle lots when the actual expiration period should have been about 5 years. according to the manufacturer’s health hazard evaluation report, this issue is unlikely to pose an incremental risk of harm. the manufacturer advises affected users to refer to the field safety notice (fsn) for the proper expiration date of the kit due to the needle. this notification does not impact any consumed product or patients with these catheters implanted. the product can be used with the understanding of the correct expiration date mentioned in the fsn. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 april 2016.