ENCOR recallZ-1431-2020 · Bard Peripheral Vascular Inc · initiated Jan 3, 2020

Why it was recalled

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.

FDA root cause category: Component change control

What the company is doing

The recalling firm issued letters dated 1/3/2020 to each of the U.S. consignees via FedEx with proof of delivery notification. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-321-4254 Option #5.

Recall details

Recall number

Z-1431-2020

Status

Terminated

Initiated by the company

Jan 3, 2020

Recalling firm

Bard Peripheral Vascular Inc

Quantity

12,875 units

Product code

KNW

FDA submissions

K040842, K051158

Distribution

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.

Product description

Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• ENCOR® ECP017G

  Senorx, Inc. · INSTRUMENT, BIOPSY
  1 recall4,186 reports

Product lines

• ENCORSenorx, Inc. · 17 models · 5,369 reports · 4 recalls

Other devices under the same FDA submission

4 devices cleared under K040842, K051158 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ENCOR® ECP017GV

  Senorx, Inc. · INSTRUMENT, BIOPSY
  243 reports
• ENCOR® ECPMR017G

  Senorx, Inc. · INSTRUMENT, BIOPSY
  1 recall0 reports
• ENCOR® ECP0112G

  Senorx, Inc. · INSTRUMENT, BIOPSY
  36 reports
• ENCOR® ECP0112GV

  Senorx, Inc. · INSTRUMENT, BIOPSY
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 84929).

• Z-1432-2020 · Terminated
  Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
• Z-1433-2020 · Terminated
  Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
• Z-1434-2020 · Terminated
  Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.