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Terminated

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.

FDA Recall Z-0199-2022 · Posted None

Recall StatusTerminated
Product CodeDXT
Date Initiated2021-09-14
Date Terminated2023-01-19
Product Quantity6,950 units

Reason for Recall

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

Firm 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 [email protected] 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.

Root Cause

Packaging process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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