FDA Alerts

Class 1 Recall: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial

Bayer has determined all Source Administration Sets used with the Medrad Intego PET Infusion System may produce a particulate matter in the medicine vials.

Thu Jan 12 2017By Jonathan Payne

Class 1 Recall: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial
 
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
 
  • Recalled Product: Medrad Intego PET Infusion System Source Administration Sets
  • Product Description: All current Source Administration Sets used with the Medrad Intego PET Infusion System
  • Batch Numbers: See full list of batch numbers below
  • Catalog Number: INT CSS
  • Distribution Dates: October 9, 2008 to October 11, 2016
  • Devices Recalled in the U.S.: 86,172 nationwide

Device Use
The Medrad Intego PET Infusion System controls and delivers medications from a chamber to a patient through a needle inserted into a vein during nuclear medicine procedures. Nuclear medicine procedures are used to diagnose and treat diseases such as cancer, thyroid disease, and heart disease.

Reason for Recall
Bayer has determined all Source Administration Sets used with the Medrad Intego PET Infusion System may produce a particulate matter in the medicine vials. The particulates may be created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.

Who May be Affected
  • Health care providers using the Source Administration Sets with the Medrad Intego PET Infusion System
  • All patient groups undergoing nuclear medicine diagnostic procedures involving the Source Administration Sets with the Medrad Intego PET Infusion System

What to Do
On November 7, 2016, Bayer sent an urgent medical device field safety corrective action notice to all affected customers. The notice asked customers to:
  • Immediately discontinue the use and quarantine any unused affected product and do one of the following:
  • Retain the quarantined Source Administration Sets to be used when the new qualified in-line filter is received.

OR

  • Quarantine Source Administration Sets stock and contact Bayer Customer Care at 1-800-633-7231 opt. 2 to receive a Returned Goods Authorization number and return the product to Bayer accordingly.
  • Complete the response form indicating if the customer does or does not have affected product. The customer should also indicate if they will retain the quarantined Source Administration Set units until they receive the in-line filter or if they will return the units back to Bayer.
  • Return the form via fax (1-412-406-0941) or email (randiproductrecalls@bayer.com).

Contact Information
Customers are instructed to contact Bayer’s Customer Care team by telephone at 1-800-633-7231, opt. 2, with any questions related to this recall.

Date Recall Initiated:
November 7, 2016
 
 

 

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