Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- January 3, 2020
- Terminated
- March 17, 2022
- Recall Number
- Z-1433-2020
- Quantity
- 2,050 units
- Firm Location
- Tempe, AZ
Reason for Recall
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.
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.
Lot / Code Info
Lot number VTCW0468; UDI number (01)00801741086304(17)200901(10)VTCW0468.
Root Cause
Component change control
Action Taken
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.