WECK¿ Horizon Manual-Load Ligating Clip Applier recalled over labeling errors

Recall date

August 24, 2016

Source

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

Official notice title

Teleflex Medical recalls WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm),…

Recall number

Z-2759-2016

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.

Why it was recalled

Misbranded: Incorrect etching on the device.

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

What was recalled

WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.