Recall Z-0199-2022 ยท DXT Injector And Syringe, Angiographic
Bayer Medical Care, Inc.
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.
| Date | Sep 14, 2021 |
| Status | Terminated |
| Reason | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) |
| Root cause | Packaging process control |
| Action | Bayer issued Urgent Medical Device Recall Letter (Recall ID: SA-21-RAD-02) dated 9/14/21 via email. Letter states reason for recall, health risk and action to take: Review your current inventory for affected Lot 8415317 and quarantine, as appropriate. 2. Complete the included response form and submit through email to CLSCRiCustomerLogistics@bayer.com or contact the Customer Logistics team at 724-940-7890. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all affected product. 3. You will receive a Return Go |
| Quantity | 6,950 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132928 | MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE Medrad, Inc. / Bayer Medical Care, Inc., Jan 23, 2014 |