Merit 1mL Medallion Syringes 의 안전성 경고

Safety alert

2018-03-05

2018-03-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180305.html

Medical device safety alert: merit 1ml medallion syringes medical device manufacturer, merit medical systems, inc., has issued a medical device safety alert concerning its 1ml medallion syringes. the affected products are identified as below: catalog numbers: a) k01-05526p; b) k01-07427; c) k01-07477p; d) k01-07930p; e) k02-00565c; f) k02-01260b; g) k02-01331a; h) k04-00748; i) k12-03636; j) mss011; k) mss011-dg; l) mss011-lg; m) mss011-pr; n) mss011-r; o) mss011-y; p) mss011-yp. lot numbers: a) h1258821; b) h1263015; c) h1242962, h1246807; d) h1246733; e) h1258361; f) h1258575, h1265248; g) h1252652; h) h1258488, h1264381; i) h1258530; j) h1242750, h1246807, h1255504; k) h1246809; l) h1246810; m) h1242752; n) h1242752, h1255507; o) h1246811; p) h1242927. the manufacturer is voluntarily conducting a recall of specific lots of 1 ml medallion syringes due to a supplier manufacturing defect with the syringe plunger tip. according to the manufacturer, prior to use and during prep, when fluid is drawn into the syringe, air may enter the barrel and/or fluid may leak out the back of the barrel. this may result in a minor delay in procedure and user dissatisfaction. it has not received any reports of patient harm or injury as a result of this issue. the manufacturer has chosen to remove the units from the market. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 march 2018.