FDA-Device2016-11-30Class II
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Hologic, Inc
Hazard
Breach in sterile barrier compromising product sterility
Sold states
Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
Affected count
600 units (US) ; 24 units (OUS)
Manufactured in
250 Campus Dr, N/A, Marlborough, MA, United States
Products
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2017Don't want to check this manually?
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