Class 2 Device Recall MEDRAD Intego PET Infusion System

• Date Initiated by Firm: November 07, 2016
• Create Date: February 08, 2017
• Recall Status: Terminated on October 18, 2017
• Recall Number: Z-0927-2017
• Recall Event ID: 75736
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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.
• Code Information: Device Listing # D053816
• Recalling Firm/ Manufacturer: Bayer Healthcare; 1 Bayer Dr; Indianola PA 15051-9702
• For Additional Information Contact: 412-767-2400
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• 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.
• Quantity in Commerce: 178,982 (86,172 units in U.S.)
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.