MEDRAD Stellant FLEX Syringe Kit recallZ-0483-2021 · Bayer Medical Care, Inc. · initiated Oct 5, 2020

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number

Z-0483-2021

Status

Terminated

Initiated by the company

Oct 5, 2020

Recalling firm

Bayer Medical Care, Inc.

Quantity

92,420 units

Product code

DXT

FDA submissions

K192370

Distribution

Distributed to healthcare facilities nationwide throughout the US.

Product description

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SCS

  Bayer Medical Care Inc. · Injector And Syringe, Angiographic
  1 recall3 reports
• MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPK

  Bayer Medical Care Inc. · Injector, Contrast Medium, Automatic
  1 recall0 reports

Product lines

• MEDRAD Stellant FLEX Syringe KitBayer Medical Care Inc. · 6 models · 13 reports · 2 recalls