FDAMay 19, 2016device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

devicor medical productsdevicordevicor medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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