Recall Z-2211-2016 ยท OIJ Biopsy Needle Guide Kit
Devicor Medical Products Inc
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
| Date | Jul 14, 2016 (initiated May 19, 2016) |
| Status | Terminated |
| Reason | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. |
| Root cause | 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. Custo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123259 | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM Devicor Medical Products, Inc., Nov 15, 2012 |