Recall Z-0655-2017— Hologic, Inc
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc, initiated 2016-10-28, terminated 2017-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound. Reason: Breach in sterile barrier compromising product sterility.
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-28
- Terminated
- 2017-08-18
- Firm location
- Marlborough, MA, United States
Product description
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
Reason for recall
Breach in sterile barrier compromising product sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.