Events

Safety Alert for Soluset 100 Burette IV Set

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Hospira de Costa Rica Ltd..

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
    2013-048
  • 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/119167-fda-advisory-no-2013-048
  • 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. 2013-048 quality hold on soluset tm 100 burette iv (intravenous) set imported by hospira philippines, inc.  in the interest of public health and safety, the food and drug administration (fda) and hospira philippines, inc. will jointly undertake a quality hold of the product solusettm 100 burette iv (intravenous ) set, with its clamp and secure lock.  hospira philippines, inc., as part of their due diligence responsibility, will do a quality check on solusettm 100 burette iv (intravenous) set found in the market, specifically those with batch numbers 1707456 and 1707856. solusettm 100 burette iv (intravenous) set is manufactured by hospira de costa rica ltd., costa rica and registered in the philippines with fda registration no. dvr-2362. all consumers and health professionals are advised not to use the said batches of solusettm 100 burette iv (intravenous) set until such time that the fda and hospira philippines, inc. shall have issued an advisory that the quality hold has been lifted.  likewise, distributors and drug outlets are ordered to remove the stocks from their shelves and hold the said stocks until the fda and hospira philippines, inc. shall have conducted the quality check.  for inquiries, email us at this email address is being protected from spambots. you need javascript enabled to view it. . for strict compliance of all concerned. attachments: fa2013-048 - quality hold on soluset 100 burette iv set imported by hospira phil.

Device

Soluset 100 Burette IV Set

Manufacturer

Hospira de Costa Rica Ltd.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    FDAP