Reported Jul 20, 2016 · Terminated

Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged…

Devicor Medical Products 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: Devicor Medical Products Inc · 300 E Business Way Fl 5 · Cincinnati, OH · 45241-2384

Mammotome Revolve Dual Vacuum
Assist Biopsy System Model numberMST1009 & 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

Lot codes and dates: MST1009 - Lot F11537107D1 Exp. Date 9-Sept
2018
MST0815 Lot F11536423D1 Exp. Date 8-Sept
2018
and
MST1009 Lot F11537109D1 Exp. Date 10-Sept
2018
Amount recalled: F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360

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

This product could cause temporary or reversible health problems — stop using it.

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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