FDA recall Z-0483-2021

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.

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.

Distribution

Distributed to healthcare facilities nationwide throughout the US.

Key facts

Status

Terminated

Initiation date

2020-10-05

Report date

2020-12-02

Termination date

2021-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianola, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2021