Medical device recalls Moderate risk

Bayer Medical Care, Inc. recalls The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate mater…

Recall date
September 14, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0199-2022
FDA classification
Class II
Brand / firm
Bayer Medical Care, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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