Cardiac Assist, Inc recalls Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Lif…

Recall date

March 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1486-2021

FDA classification

Class II

Brand / firm

Cardiac Assist, Inc

Sold / distributed

US Nationwide distribution in the states of AL, AZ, IL, TN.

Why it was recalled

On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)