Device product
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Z-0655-2017
Product summary
- Firm
- Hologic, Inc
- Event
- Event 75558
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 units (US) ; 24 units (OUS)
- Official record key
device-enforcement:Z-0655-2017
Official wording
Reason: Breach in sterile barrier compromising product sterility
Code information: Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB
Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
Derived failure modes
-
Sterility assurance
Breach in sterile barrier