FDA-Device2023-07-05Class II
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Hologic, Inc
Hazard
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Sold states
US Nationwide distribution.
Affected count
756 units
Manufactured in
250 Campus Dr, N/A, Marlborough, MA, United States
Products
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2023Don't want to check this manually?
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