# FDA recall Z-0199-2022

> **Bayer Medical Care, Inc.** · Class II · device recall initiated 2021-09-14.

## 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.

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL,  NZ, RU, SE, TH.

## Key facts

- **Recall number:** Z-0199-2022
- **Recalling firm:** Bayer Medical Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-14
- **Report date:** 2021-11-10
- **Termination date:** 2023-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianola, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2022

## Citation

> AI Analytics. FDA recall Z-0199-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0199-2022. Source: US FDA. Licensed CC0.

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