Events

Safety Alert for Articulated Cannulas Aortic Sarns (Sarns Aortic Arch Cannulae) with 3/8-inch connectors: (1) 6.5 mm, (2) 8 mm 24 Fr Flexible, (3) 6.5 mm 20 Fr High Flow with Suture Flange and Luer Port, (4) 24 Fr Flexible reinforced wire with Luer Port (Wire-Reinforced Flex with Luer Port); (5) 24 Fr Sarns Flexible Cannulae NW-Soft Flexible Articular Cannulae with Vented Cap Markings with Vented Cap, Luer Port, and 3/8-inch Connector. In the Catalog: (1) 98-0702-0710-9, (2) 4335, (3) 15495, (4) 98-0702-1447-7, (5) 98-0702-1286-9; Lots Nos .: (1) W507618; (2) W50743, 236511; (3) 236148, 238279, 241991; (4) W507617; (5) W507538, 236153

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Terumo Cardiovascular Systems Corp Div Terumo Medical Corp.

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
  • Event ID
    178
  • Date
    2001-03-06
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    BRAZIL - 08/11/2001 - TERUMO MEDICAL COMPANY OF BRAZIL, INFORMES THAT THE PROVIDENCIES OF TRACKING THE INDICATED PRODUCTS AND IT WAS DETECTED ONLY ONE DISTRIBUTOR WITH ONE ITEM, AND CLARES THAT THOUGH THE IMPORTED PRODUCT CODE WAS EVEN IN THE RECALL LIST , THE SAME DOES NOT OCCUR WITH THE LOT NUMBER. THEREFORE, IT HAS NOT IN BRAZIL NO PRODUCT OF THAT PASSIVEL NUMBER OF RECALL NEEDS. INFORMS THAT YOU TRANSLATED THE LETTER RECALL AND REPAYED TO THE DISTRIBUTOR, AND THAT ALL THE NECESSARY MEASURES WERE TAKEN TO YOUR CUSTOMER TO ENSURE THE QUALITY OF THE PRODUCT.
  • Reason
    There may be a crack in the connector near the junction between the connector and the cannula tube in the aforementioned batches of the product. the crack in the connector can cause air to enter the perfusion circuit under low or no flow conditions, which may necessitate surgical replacement of the cannula.
  • Action
    Make sure you have received the letter of March 6, 2001 from Terumo Cardiovascular Systems. Identify, isolate, and immediately stop using any affected product in your stock. To obtain a Product Return Authorization, number and return the affected products to Terumo Cardiovascular Systems. P to receive credit or exchange, contact your customer service representative at tel. (800) 521-2818 within the US, or your local Terumo sales representative outside the US. For more information, contact Brian Dawson, Terumo Cardiovascular Systems, at (800) 238-7866, ext. 6066, within the US, or tel. (734) 663-4145 outside the US.

Device

Articulated Cannulas Aortic Sarns (Sarns Aortic Arch Cannulae) with 3/8-inch connectors: (1) 6.5 ...

Manufacturer

Terumo Cardiovascular Systems Corp Div Terumo Medical Corp
  • Source
    ANVSANVISA