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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bayer Medical Care, Inc.
Lot Codes / Batch Numbers
Batch number: 8415317
Products Sold
Batch number: 8415317
Bayer Medical Care, Inc. is recalling The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear due to Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Recommended Action
Per FDA guidance
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 Goods Authorization (RGA) number to return any affected Syringe kits remaining in your inventory for a credit. We can send new syringe kits with a separate purchase order, as necessary. 4. Place the affected product in a box and label the outside of the container with the RGA number in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return affected product no later than November 30, 2021. 5. Upon Bayer receipt of returned product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your facility who may need to maintain awareness of this recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026