The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a cle...

FDA Device Recall #Z-0199-2022 — Class II — September 14, 2021

Recall Summary

Recall Number Z-0199-2022
Classification Class II — Moderate risk
Date Initiated September 14, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bayer Medical Care, Inc.
Location Indianola, PA
Product Type Devices
Quantity 6,950 units

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)

Distribution Pattern

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

Lot / Code Information

Batch number: 8415317

Other Recalls from Bayer Medical Care, Inc.

Recall # Classification Product Date
Z-0910-2023 Class II Source Administration Set (SAS) used with the M... Nov 30, 2022
Z-0483-2021 Class II Brand Name: MEDRAD Stellant FLEX Syringe Kits ... Oct 5, 2020
Z-0745-2019 Class II MAVIG Portegra or Portegra2 Overhead Counterpoi... Dec 14, 2018
Z-0097-2019 Class II Codan Filter (Codan catalog number BC 693) used... Sep 7, 2018
Z-2961-2018 Class II Overhead Counterpoise Systems (OCS) OCS CONF an... Jun 28, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.