Events

Recall of Device Recall MEDRAD Intego PET Infusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer Healthcare.

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
    75736
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-2017
  • Event Initiated Date
    2016-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151118
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    Bayer has determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted.
  • Action
    Bayer mailed an Urgent Medical Device Field Safety Notice dated November 3. 2017 to affected customers to inform them of the issue. Customers were asked to immediately quarantine unused product and resume use once the qualified in-line filter is received or to request a RGA (Return Goods Authorization) number to return the product. Customers were asked to complete the response form indicating if their institution does or does not have affected product and return the form via fax to 1-412-406-0941. Customers with questions were instructed to contact the Customer Care team at 1-800-633-7231, opt 2. For questions regarding this recall call 412-767-2400. On December 5, 2016, the recalling firm sent a new letter indicating the inline filter has been successfully tested and that they have qualified a compatible in-line filter to be used with the Patient Administrative Set (PAS) that will allow you to resume use of your Intego system.

Device

Device Recall MEDRAD Intego PET Infusion System
  • Model / Serial
    Device Listing # D053816
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    MEDRAD Intego PET Infusion System - Pump || Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Manufacturer Address
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    USFDA