Bayer Healthcare: Medical Device Recall in 2017 - (Recall #: Z-0927-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 7, 2016

Date Posted: February 15, 2017

Recall Number: Z-0927-2017

Event ID: 75736

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.

Status: Terminated

Product Quantity: 178,982 (86,172 units in U.S.)

Code Information:

Device Listing # D053816

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated