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Devicor Medical Products Inc recalls Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged w
Recalled July 20, 2016 · FDA recall Z-2211-2016 · Devicor Medical Products
Hazard
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. · FDA Class II
Units
F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360
Sold at
Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
Description
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
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.
Manufacturer(s)
Devicor Medical Products Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →