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

FDA device recall Z-2211-2016 · posted 2016-07-14 · Terminated

Recall details

Recalling firm

Devicor Medical Products Inc

Reason for recall

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

Action taken

An Urgent: Medical Device Recall of Mammotome Revolve Dual Vacuum Assist Biopsy Probe due to Potential Product Code Mislabel communication was sent to the customers via 1st class USPS on June 6, 2016. The labeling and the Customer response form was also attached. Customers were asked to examine their inventory and quarantine the affected product. If the product was further distributed, those customers are to be identified and notified. The letter stated that the assigned sales rep would be in contact to support the identification, inspection and replacement of the recalled products. Customers are to complete and return the enclosed response form. Questions are to be directed to Mammatome Customer Service 1-877-926-2666.

Root cause

Packaging

Status

Terminated

Product code

OIJ

Quantity affected

F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360

Distribution

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

Date initiated

2016-05-19

Date posted

2016-07-14

Date terminated

2017-08-03

Location

Cincinnati, OH

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