Safety Alert for Stay Safe Disinfection Cap

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Fresenius Medical Care Philippines, 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 Number
    2018-213
  • Event Country
  • Event Source
    FDAP
  • Event Source URL
  • 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. 2018-213 voluntary recall of stay safe disinfection cap with batch number z1z04300 the food and drug administration (fda) informs the public and all concerned healthcare professionals that fresenius medical care philippines, inc. has voluntarily recalled the stay safe disinfection cap with batch number z1z04300. it has been discovered that this batch number was distributed without local label sticker. the application stickers for the mentioned batch was missed by their sub-distributor. appropriate corrective and preventive actions will be instituted to prevent recurrence.  as a mitigating measure they will provide replacement of the said medical device product to the affected customers to ensure continuity of care. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-213.Pdf.

Manufacturer