Recall Z-2211-2016— Devicor Medical Products Inc

Name: FDA recall Z-2211-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-19

Class II · Terminated

Class II FDA medical device recall by Devicor Medical Products Inc, initiated 2016-05-19, terminated 2017-08-03. It names one FDA 510(k) clearance: K123259. Product: Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.. Reason: A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package..

Recalling firm: Devicor Medical Products Inc
Classification: Class II
Status: Terminated
Initiated: 2016-05-19
Terminated: 2017-08-03
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K123259 — MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEMDevicor Medical Products, Inc.·cleared 2012-11-15

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

Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

Reason for recall

A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

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