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
    2014-046
  • 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/164059-fda-advisory-no-2014-046
  • 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. 2014-046 lifting of the quality hold in soluset 100 burette intravenous iv set imported by hospira philippines inc on 04 november 2013, fda advisory no. 2013-048; quality hold on soluset 100 burette iv (intravenous) set imported by hospira philippines inc was issued to conduct quality check. testing was conducted by the laboratory unit of food and drug administration on 09 december 2013 on 18 sets of soluset burette intravenous (iv) set batch number 170785g. the test has a satisfactory result and passed the sterility test.  a seperate investigation was conducted by hospira philippines, on all the remaining stocks of soluset tm burette intravenous (iv) set. historical complaints search, review of the batch record, evaluation of the inspection results of visual checking and physical evaluation of the two lot numbers invloves were conducted by the company. this resulted to no discrepancies that may have contributed to the complaint are improper use of hairnet and gowning during the coiling, packaging or sealing process. the qa/production management personnel of hospira were notified. proper gowning and wearing of hairnet was implemented in the clean room to mitigate this kind of problem from occurring. in this regard, the quality hold on solucet tm burette intravenous (iv) set imported by hospira philippines inc. with batch number 170145g and 170785g is hereby lifted effective immediately. hospira philippines inc can now sell the products       attachments: fa2014-046.Pdf.

Device

Soluset 100 Burette IV Set

Manufacturer

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