Abbott Medical recalls CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radi…

Recall date

November 11, 2019

Source

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

Recall number

Z-0720-2020

FDA classification

Class II

Brand / firm

Abbott Medical

Sold / distributed

Worldwide distribution - US Nationwide and country of Bermuda.

Why it was recalled

A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.

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

What was recalled

CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.