Z-0199-2022Class II

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

Name: Z-0199-2022 The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear...
Creator: Bayer Medical Care, Inc.
Published: 2021-09-14
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2021-09-14 / Terminated / root cause: packaging

FDA source

Bayer Medical Care, Inc. began a recall of 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... on 2021-09-14. FDA classified it as Class II and gives the reason as "Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0199-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-14
Posted: 2021-11-03
Terminated: 2023-01-19
Recalling firm: Medrad, Inc.
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.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Root cause tag: packaging
FDA 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 [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.
Quantity in commerce: 6,950 units
Distribution: Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Product codes and lots: Batch number: 8415317

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0199-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-03

Product code DXT

K132928Class IIMedrad Mark 7 Arterion Injection System / Syringe, Twist & Go SyringeMedrad, Inc. / Bayer Medical Care, Inc. / cleared 2014-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)