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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip

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  Class 2 Device Recall Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip see related information
Date Initiated by Firm January 03, 2020
Create Date March 03, 2020
Recall Status1 Terminated 3 on March 17, 2022
Recall Number Z-1434-2020
Recall Event ID 84929
510(K)Number K051158  K040842  
Product Classification Instrument, biopsy - Product Code KNW
Product Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Code Information Lot number VTCV0370; UDI number (01)00801741086311(17)200801(10)VTCV0370.
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact Ms. Janice Norwood
800-321-4254
Manufacturer 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.
FDA Determined
Cause 2		 Component change control
Action 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.
Quantity in Commerce 1,085 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = SENORX, INC.
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