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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Devicor Medical Products Inc
- Reason for Recall:
- A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2211-2016
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