Devicor Mammotome Biopsy System Recalled for Incorrect Needle Packaging
Devicor Medical Products is recalling Mammotome Revolve biopsy systems because 10-gauge needles were shipped in 8-gauge packages.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm due to incorrect needle size packaging, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Devicor Medical Products Inc. is recalling specific lots of the Mammotome Revolve Dual Vacuum Assist Biopsy System, models MST1009 and MST0815. The recall was initiated because a 10-gauge needle, 9 cm long, was shipped in an 8-gauge needle, 15 cm package. This packaging error could lead to the use of the wrong needle size during a procedure.
The affected units are labeled as sterile and are intended to provide breast tissue for histologic examination. The recall covers specific lot numbers: F11537107D1 (Model MST1009), F11536423D1 (Model MST0815), and F11537109D1 (Model MST1009). The total quantity involved is 800 units.
These devices were distributed worldwide, including in the United States (specifically in states such as 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 in Canada, Japan, Korea, and The Netherlands. Healthcare providers and facilities should stop using the affected lots and contact Devicor Medical Products for instructions on return or replacement.
The recalled product
- 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 a
- Manufacturer
- Devicor Medical Products Inc
- Category
- Medical Device — Biopsy System
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- MST1009 - Lot F11537107D1 Exp. Date 9-Sept
- 2018
- MST0815 Lot F11536423D1 Exp. Date 8-Sept
- and
- MST1009 Lot F11537109D1 Exp. Date 10-Sept
- 2018.
Distribution
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