Angiodynamics Soft Vu Omni Flush Angiographic Catheter 의 안전성 경고

Safety alert

2016-07-25

2016-07-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160725c.html

Medical device safety alert: stryker sustainability solutions (formerly ascent healthcare solutions) angiodynamics soft vu omni flush angiographic catheter the food and drug administration (fda) of the united states has issued a medical device safety alert concerning angiodynamics soft vu omni flush angiographic catheter, manufactured by stryker sustainability solutions (formerly ascent healthcare solutions). the affected devices are identified as follows:- lot numbers: 8248u, 119965u, 158623u, 175183u, 179688u, 191185u, 210813u,225911u, 225918u, 225919u, 253202u, 277726u, 302844u, 309329u, 325680u, 343908u, 352756u, 352761u, 359352u, 363987u, 366572u, 369818u, 375883u, 772102u, 773196u, 773216u, 775985u, 7710750u manufacturing dates: november 7, 2003 to october 18, 2008 distribution dates: january 5, 2004 to december 3, 2008 according to the fda, the manufacturer is recalling angiodynamics soft vu omni flush angiographic catheters due to reports of separation of the tip of the catheter from the main body. tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs. tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death. the manufacturer sent a customer notification letter to affected customers informing them of the high possibility of tip separation during use and customers are advised to discontinue use of the affected lots of the recalled products. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm512644.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm512633.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2016.