Bayer Medical Care, Inc.: 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.

Recall number

Z-0483-2021

Recalling firm

Bayer Medical Care, 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.

Status

Terminated

Initiated

2020-10-05

Posted

not on file

Terminated

2021-03-19

Reason

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

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 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. 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

92,420 units

Distribution

Distributed to healthcare facilities nationwide throughout the US.

Lot, serial or model codes

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

510(k) numbers

["K192370"]

PMA numbers

not on file

Product code

DXT

Firm FEI

2520313

Firm city

Indianola

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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