Events

Safety Alert for Infusion Pump, Intravascular Gravity Management Equipment: (1) Key, (2) Horizon Key, (3) Primary Key ADDitIV, (4) Horizon Primary ADDitIV, (5) Primary ADDitIV, (6) SafeLine Horizon, ) SafeSite Horizon, (8) Ultrasite, (9) Ultrasite Horizon, (10) Ultrasite View, (11) View. Catalog Nos .: CC1270, CC1271, CC1290, CC3130, CC3130-SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, NF3140D, NF3160, NF6413, SS3140, SS3160, SS6413, US3131, V1443, V1444-12, V1445, V1445-24, V1445-30, V1445-44, V1446, V1447, V1449-12, V1452, V1453, V1464, V1484, V1485, V1785, V6410, V6413, V6430, V7210, V7410, V7410-10; Lots Nos .: 60202059, 60204396, 60204396, 60204396, 60206655, 60206655, 60201171, 60211414, 60213590, 60213590, 60213594, 60218860, 60218346, 60218349, 60218373, 60218607, 60219461, 60219481, 60221910, 60223949, 60223965, 60223973, 60223976, 6024430, 60230296, 60230296, 60223036, 60223036, 60223036, 60230342, 60235822, 60235929, 60236775, 60236775, 60243610, 60243109, 60243129, 60243132, 60243132, 60243135, 60243136, 60243138, 60243583, 60243586, 60243588, 60243599, 60244153 to 60244155, 60244180, 60244514, 602445149, 602445149, 602445169, 602445169, 602445169, 602445169, 602445169, 602445409, 602445409, 602445169, 602445169, 602445169, 602445169, 60255960, 60255930, 60255930, 60255930, 60255930, 60255960, 60255960, 60255960, 60255960, 60255960, 60255960, 60255910, 60255310, 60255310, 60255310, , 60256167, 60256167, 60256177, 60256177, 60256147, 60256147, 60256147, 60256147, 60256157, 60256157, 60256162, 60257354, 60257373, 60258119, 60258158, 60258159, 60258169, 60258163, 60258167, 60258168, 60259837, 60259868, 60260586, 60260587, 60260592, 60260594, 60260607, 60261961, 60261976, 60261976, 60261976, 60261917, 60262821, 60262839, 60262839, 60262849, 60262819, 60263719, 60263724, 60263725, 60263252, 60263859, 6026455, 60264606, 60264609, 60264613, 60264614, 60264620, 60265844, 60265845;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by B Braun Medical Inc.

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
    397
  • Date
    2002-02-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The infusion pump management set above may disconnect from the drip chamber. the manufacturer initiated the correction by letter dated 10 october 2001. the firm did not provide any information to ecri.
  • Action
    Verify that you received the letter dated 10 October 2001 from B. Braun Medical. Identify and isolate any affected product in your inventory. For more information, contact B. Braun Medical at (1610) 691-5400 or your local B. Braun Medical representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Infusion Pump, Intravascular Gravity Management Equipment: (1) Key, (2) Horizon Key, (3) Primary ...

Manufacturer

B Braun Medical Inc
  • Source
    ANVSANVISA