Z-0927-2017 Class II Terminated
FDA device recall Z-0927-2017 was initiated by Bayer Healthcare on November 7, 2016 and is designated Class II. 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 ins… The recall status is terminated (terminated October 18, 2017). Affected quantity: 178,982 (86,172 units in U.S.).
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- November 7, 2016
- Termination Date
- October 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178,982 (86,172 units in U.S.)
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.
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.
Distribution Pattern
Nationwide Distribution
Code Information
Device Listing # D053816