Bayer Medical Care, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0483-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 5, 2020

Date Posted: December 2, 2020

Recall Number: Z-0483-2021

Event ID: 86619

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.

Status: Terminated

Product Quantity: 92,420 units

Code Information:

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

Distribution Pattern:

Distributed to healthcare facilities nationwide throughout the US.

Voluntary or Mandated:

Voluntary: Firm initiated