Device product
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Z-0199-2022
Product summary
- Event
- Event 88807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,950 units
- Official record key
device-enforcement:Z-0199-2022
Official wording
Reason: Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Code information: Batch number: 8415317
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Derived failure modes
-
Labeling or packaging
Labeling error