Events

Safety Alert for Angiodynamics Soft Vu Omni Flush Angiographic Catheter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Stryker Sustainability Solutions.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-07-25
  • Event Date Posted
    2016-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160725c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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.

Device

Angiodynamics Soft Vu Omni Flush Angiographic Catheter
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Angiodynamics Soft Vu Omni Flush Angiographic Catheter
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH