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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G

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 Class 2 Device Recall Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7Gsee related information
Date Initiated by FirmJanuary 03, 2020
Create DateMarch 03, 2020
Recall Status1 Terminated 3 on March 17, 2022
Recall NumberZ-1431-2020
Recall Event ID 84929
510(K)NumberK040842 K051158 
Product Classification Instrument, biopsy - Product Code KNW
ProductBard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Code Information Lot numbers VTCT0268, VTCT0269, VTCT0270, VTCT0271, VTCU0340, and VTCU0341.   UDI numbers: (01)00801741086281(17)200601(10)VTCT0268, (01)00801741086281(17)200601(10)VTCT0269, (01)00801741086281(17)200601(10)VTCT0270, (01)00801741086281(17)200601(10)VTCT0271, (01)00801741086281(17)200601(10)VTCU0340, and (01)00801741086281(17)200601(10)VTCU0341.
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information ContactMs. 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
ActionThe 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 Commerce12,875 units
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = KNW
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