Events

Recall of Device Recall MEDRAD Intego PET Infusion System, Source Administration Set

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
    72817
  • Event Risk Class
    Class 2
  • Event Number
    Z-0627-2016
  • Event Initiated Date
    2015-11-30
  • Event Date Posted
    2016-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142291
  • 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
    The firm's investigation of the medrad intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an rp prime fail.
  • Action
    Bayer Healthcare sent an "Urgent Medical Device Field Corrective Action" letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately take the following steps. Please review your current inventory. Do not use any Source Administration Sets (SAS) with the impacted batch numbers that are included in the index below. If you have unused affected product, immediately quarantine the product and please call Bayer Customer Service at 1-800-633-7231 to receive a Returned Goods Authorization (RGA) number and return the product immediately to Bayer accordingly. Please complete the response form and fax it to Bayer at 1-412-406-0942 or e-mail to randiproductrecalls@bayer.com, whether or not you have impacted product. To provide you with new product, please submit a new product order. Please note that due to limited new inventory, there may be a delay in fulfillment. New batches of SAS are currently being shipped and lead times will be dependent on available supply until inventory returns to normal levels. We appreciate your cooperation and sincerely regret any inconvenience. We are committed to providing effective products and service to support your patient care. If you have questions, please contact our customer support team at 1-800-633-7231.

Device

Device Recall MEDRAD Intego PET Infusion System, Source Administration Set
  • Model / Serial
    50856405, 50857510, 50860994, 50866789, 50867921, 50869464, 50869465, 50871131, 50872965, 50878229, 50878230, 50878231, 50878232, 50881328, 50881393, 50881394, 50881395, 50881506, 50881511, 50881512, 50882753, 50886316, 50886467, 50886468, 50886469, 50888285, 50888286, 50888287, 50888288, 50888373, 50890483, 50890484, 50890485, 50892357, 50892358, 50892359, 50892360, 60000321, 60000322, 60000323, 60000692, 60000789, 60000790, 60000833, 60000834, 60000835
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.
  • Product Description
    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in 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