Recall Z-2869-2016— Hologic, Inc

Name: FDA recall Z-2869-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-22

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc, initiated 2016-08-22, terminated 2017-02-03. It names one FDA 510(k) clearance: K150169. Product: Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.. Reason: Incorrect label on the Sertera Biopsy Kit.

Recalling firm: Hologic, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-22
Terminated: 2017-02-03
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150169 — Sertera Biopsy DeviceHologic, Inc.·cleared 2015-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

Reason for recall

Incorrect label on the Sertera Biopsy Kit

Data sourced from openFDA. This site is unofficial and independent of the FDA.