Multi-Med Single Lumen Catheters 의 안전성 경고

Safety alert

2016-12-12

2016-12-12

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20161212a.html

Medical device safety alert: centurion multi-med single lumen catheters the united states food and drug administration (fda) has issued medical device safety alerts concerning multi-med single lumen catheters manufactured by centurion. the affected devices are identified as follows:- product code: foz centurion kit codes: ecvc1680, ecvc4785, m11620hkic, m11620hkicnl, m11620hs, m11620kc, m11620kcnl, m12013k, m12013knl lot numbers: 2016062150, 2016062950, 2016070650, 2016081550, 2016051050 2016053150, 2016060750, 2016061550, 2016063050, 2016072050, 2016080250, 2016091950, 2016060750, 2016072650, 2016093050, 2016101050, 2016052050, 2016062850, 2016082350, 2016082650, 2016090250, 2016050950, 2016053150, 2016060750, 2016071250, 2016080350, 2016082950, 2016060850, 2016061650, 2016062050, 2016070550, 2016071950, 2016080250, 2016090750, 2016071350, 2016072050, 2016092650, 2016100650, 2016072950, 2016082450 distribution date: 23 may 2016 to 18 oct 2016 the manufacturer is recalling the centurion convenience kits containing multi-med single lumen catheters. the catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. if this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. this can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death. customers are asked to identify and stop using the affected products in their inventory. for details, please refer to the fda website: medwatch: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm532629.Htm medical device recalls:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm532576.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2016.