Z-0483-2021Class II

Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number...

Name: Z-0483-2021 Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number...
Creator: Bayer Medical Care, Inc.
Published: 2020-10-05
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2020-10-05 / Terminated / root cause: manufacturing process

FDA source

Bayer Medical Care, Inc. began a recall of Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1... on 2020-10-05. FDA classified it as Class II and gives the reason as "Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0483-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-05
Posted: 2020-11-23
Terminated: 2021-03-19
Recalling firm: Medrad, Inc.
Product: Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 10/08/020, Bayer sent all of their affected customers an Urgent Medical Device Field Corrective Action (recall) letter via e-mail. The recall letter requested that all of the affected customers immediately take the following steps: 1. Review your current inventory. Quarantine any affected batch/lot numbers referenced in the below chart. Instructions are included in this letter on how to identify batch/lot. 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. If product is needed immediately to avoid a stock out, expedited shipping options will be available. For expedited shipping options, please contact the Customer Logistics team at 724-940-7890. 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 the RGA number. 5. Upon Bayer receipt of return product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your institution who may have inventory that may be affected by this field corrective action.
Quantity in commerce: 92,420 units
Distribution: Distributed to healthcare facilities nationwide throughout the US.
Product codes and lots: Catalog/REF Number: FLEXD-150-SCS Material Number: 87078817 Lot Numbers: 8584324, 8586383, 8586384, 8586385, 8586386, 8586388 UDI Numbers: (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 Catalog/REF Number: FLEXD-150-SPK Material Number: 85020218 Lot Number: 8585234 UDI Numbers: (01)00616258010656(11)200720(17)240720(10)8585234

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0483-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0483-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-23

Product code DXT

K192370Class IIMEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. / cleared 2019-12-13

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)