FDAFDA · Food and drugs·Recall number Z-2649-2016
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Published August 31, 2016 · Recall initiated: July 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bovie Medical Corporation
- Distributor
- Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
- Lot
- Lot 0316D.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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