Abbott Vascular recalls StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

Recall date

February 10, 2017

Source

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

Recall number

Z-1202-2017

FDA classification

Class II

Brand / firm

Abbott Vascular

Sold / distributed

US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,

Why it was recalled

Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.

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

What was recalled

StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.