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Hologic, Inc recalls SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) c
Recalled November 30, 2016 · FDA recall Z-0655-2017 · Hologic
Hazard
Breach in sterile barrier compromising product sterility · FDA Class II
Units
600 units (US) ; 24 units (OUS)
Sold at
Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
Description
Breach in sterile barrier compromising product sterility
Product
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →