FDA Device recall Z-2211-2016
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815 by Devicor Medical Products, citing A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2211-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-19 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Devicor Medical Products |
| Distribution | 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, WI |
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.
Reason
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2211-2016%22
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