Bayer Medical Care, Inc. Recall 88807
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.
Bayer Medical Care, Inc. Recall 88807 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0199-2022 |
| Event ID | 88807 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH. |
| Quantity | 6,950 units |
| Recall Reason | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) |
| Device Classification | 20211110 |
| Device Code Info | Batch number: 8415317 |
| Center Classification Date | 20211103 |
| Recall Initiation Date | 20210914 |
| Recalling Firm | Bayer Medical Care, Inc. |
| Initial Notification | Letter |
| Similar To |