FDAFDA · Food and drugs·Recall number Z-1433-2020
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Published March 11, 2020 · Recall initiated: January 3, 2020
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
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Peripheral Vascular Inc
- Distributor
- Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
- Lot
- Lot number VTCW0468; UDI number (01)00801741086304(17)200901(10)VTCW0468.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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