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U.S. Department of Health and Human Services

Class 2 Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System

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  Class 2 Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System see related information
Date Initiated by Firm May 19, 2016
Date Posted July 14, 2016
Recall Status1 Terminated 3 on August 03, 2017
Recall Number Z-2211-2016
Recall Event ID 74297
510(K)Number K123259  
Product Classification Biopsy needle guide kit - Product Code OIJ
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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Devicor Medical Products Inc
300 E Business Way Fl 5
Cincinnati OH 45241-2384
For Additional Information Contact John Scott Ehlert
513-864-9158
Manufacturer Reason
for Recall		 A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
FDA Determined
Cause 2		 Packaging
Action 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.
Quantity in Commerce 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, Korea, and The Netherlands.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OIJ and Original Applicant = DEVICOR MEDICAL PRODUCTS, INC.
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