FDA-Device2021-11-10Class II
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.
Bayer Medical Care, Inc.
Hazard
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Sold states
Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Affected count
6,950 units
Manufactured in
1 Bayer Dr, N/A, Indianola, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2022Don't want to check this manually?
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