Device product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.
Z-0910-2023
Product summary
- Event
- Event 91273
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2840 units
- Official record key
device-enforcement:Z-0910-2023
Official wording
Reason: Black specks may be present on the packaged needles
Code information: UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
Derived failure modes
-
Unknown
Black specks may be present on the packaged needles