Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters 의 안전성 경고

Safety alert

2016-09-21

2016-09-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160921.html

Medical device safety alert: vascular solutions twin-pass, twin-pass rx and twin-pass .023" catheters medical device manufacturer, vascular solutions, inc., has issued a medical device safety alert concerning its twin-pass, twin-pass rx and twin-pass .023" catheters. [model numbers: 5200, 5210, 5230; lot numbers: 575653, 577278, 577279, 577761, 577762, 578419, 578996, 578997, 579472, 5797s7, 580186, 580612, 580613, 581252, 582138, 582579, 582580, 583021, 583785, 584155, 584156, 584463, 584812, 585176, 585784, 585785, 586310, 586399, 587030, 587407, 587772, 588499, 588542, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 590739, 591037, 591261, 591262, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593696, 593717, 593985, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037]. the manufacturer has become aware of a potential problem with their twin-pass (5200), twin-pass rx (5210) and twin-pass .023” (5230) dual access catheters. investigation concluded that there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. it is possible that the excess material may separate from the catheter during a procedure, which poses a potential risk of an embolism to the patient. according to the manufacturer, there have been no reports of adverse patient events related to this issue. the manufacturer is voluntarily recalling and replacing all affected units of twin-pass, twin-pass rx and twin-pass .023”. 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 21 september 2016.