Reported Jul 5, 2023 · Ongoing
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the…
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?
- Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft
- tissue and tumors of the breast REFSERTERA-14
- Lot codes and dates
- UDI-DI15420045504066
- Lot NumberE22H19RM
- Amount recalled
- 756 units
Where it was sold
- Nationwide
Why it was recalled
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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