FDA-Device2020-03-11Class II
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Bard Peripheral Vascular Inc
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.
Sold states
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.
Affected count
12,875 units
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1431-2020Don't want to check this manually?
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