Events

Recall of Medstream 81" (206 cm) 20 drop Universal Administration Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by US Infusion Inc dba Trucare Biomedix-USA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70143
  • Event Risk Class
    Class 2
  • Event Number
    Z-1277-2015
  • Event Initiated Date
    2014-10-10
  • Event Date Posted
    2015-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132319
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    Several complaints regarding the iv sets leaking at the y site.
  • Action
    On December 10, 2014 the firm sent an URGENT DRUG RECALL to its consignees. Instructions were to immediately examine inventory and quarantine all product subject to the recall. Customers were asked to complete and return the response form. For returned goods instructions contact Roberta Parness at 866-593-8444 or via email at rparness@tcbiomedix.com.

Device

Medstream 81" (206 cm) 20 drop Universal Administration Sets

Manufacturer

US Infusion Inc dba Trucare Biomedix-USA
  • Manufacturer Address
    US Infusion Inc dba Trucare Biomedix-USA, 6356 Manor Ln, Suite 103, South Miami FL 33143-4960
  • Manufacturer Parent Company (2017)
    Us Infusion Dba True Care
  • Source
    USFDA