Recall Z-0927-2017— Bayer Healthcare
Class II · Terminated
Class II FDA medical device recall by Bayer Healthcare, initiated 2016-11-07, terminated 2017-10-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Bayer Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-07
- Terminated
- 2017-10-18
- Firm location
- Indianola, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.