Hologic, Inc recalls SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) c…

Recall date

October 28, 2016

Source

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

Recall number

Z-0655-2017

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.

Why it was recalled

Breach in sterile barrier compromising product sterility

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

What was recalled

SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound