Events

Safety Alert for AV-Set B DT INF-E Blood Tubing System

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

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 Number
    2018-240
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525285-fda-advisory-no-2018-240
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-240 termination of the voluntary recall of  av-set b dt inf-e blood tubing system with dvr no. 8574 (article no. ap16641) the food and drug administration (fda) informs the public that fresenius medical care philippines, inc., marketing authorization holder (mah), has reported that it has completed the recall and removal of av-set b dt inf-e blood tubing system (see figures 1 and 2) with dvr no. 8574 (article no. ap16641) from the philippine market. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-240.Pdf.

Device

AV-Set B DT INF-E Blood Tubing System
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP