Reported Nov 30, 2016 · Terminated
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution)…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
- Lot codes and dates
- Lot Code US16E25RC 16E25RD 16F16R
- Lot Code OUS16E25RB
- Amount recalled
- 600 units (US) ; 24 units (OUS)
Where it was sold
- Nationwide
Why it was recalled
Breach in sterile barrier compromising product sterility
This product could cause temporary or reversible health problems — stop using it.
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