Events

Safety Alert for Nonvented Y-Set

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hospira.

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
  • Date
    2014-04-17
  • Event Date Posted
    2014-04-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140417.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hospira nonvented y-set medical device manufacturer, hospira, has issued a medical device safety alert concerning its nonvented y-set for transurethral resection (list number: 06543-01). the impacted batches are 13106ns, 13170ns, 13251ns, 14261ns, 14262ns, 15139ns, 16117ns, 17131ns, 17132ns, 17184ns, 18110ns, 18111ns, 18182ns, 19133ns, 20122ns, 20123ns, 20124ns, 20205ns, 22146ns, 22147ns, 22148ns, 22149ns, 23103ns, 23104ns, 23105ns, 23106ns, 24156ns, 25130ns, 25131ns, 27109ns, 27253ns, 27286ns, 28136ns, 28137ns, 29094ns, 29095ns, 29096ns, 30194ns, 30195ns, 30196ns, 31042ns, 31043ns, 32229ns, 32230ns, 33138ns, 33139ns, 33140ns, 34286ns and 35117ns. in the complaint review, the manufacturer has discovered the issue of incomplete sealing in the secondary package of the affected batches of devices. the issue occurred either because the sterile pack was not sealed properly or the tyvek cover sheet was not centered on the bottom tray of the pack, allowing openings at the edge of the sterile package. the open packaging of the affected product may lead to loss of product sterility, delay in initiating therapy, introduction of infectious agent and particulate onto the surface of the irrigation set. up to date, the manufacturer did not receive any complaint or adverse reporting associated with the incomplete sealing of the package. the manufacturer advises affected users not to use the package if it is not intact. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 april 2014.

Device

Nonvented Y-Set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Nonvented Y-Set
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DH