PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 10, 2021 Initiated: September 14, 2021 #Z-0199-2022

Product Description

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.

Reason for Recall

Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)

Details

Recalling Firm
Bayer Medical Care, Inc.
Units Affected
6,950 units
Distribution
Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Location
Indianola, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bayer Medical Care, Inc.. Units affected: 6,950 units.
Why was this product recalled?
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Which agency issued this recall?
This recall was issued by the FDA Devices on November 10, 2021. Severity: Moderate. Recall number: Z-0199-2022.