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U.S. Department of Health and Human Services

Class 2 Device Recall EnCor Breast Biopsy Probe

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  Class 2 Device Recall EnCor Breast Biopsy Probe see related information
Date Initiated by Firm May 02, 2019
Create Date August 07, 2019
Recall Status1 Terminated 3 on March 03, 2022
Recall Number Z-2209-2019
Recall Event ID 83303
510(K)Number K040842  K051158  
Product Classification Instrument, biopsy - Product Code KNW
Product EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Code Information Lot numbers VTCT0306, VTCT0307, VTCU0358 VTCU0359, VTCU0360, VTCU0361, VTCV0369, VTCW0454, VTCW0455, VTCW0456, VTCW0479, VTCX0482, VTCX0483, VTCX0484, VTCY0536, VTCY0544, VTCY0545, VTCY0546, VTCY0547, VTCZ0637, VTCZ0638, VTCZ0639, VTCZ0641, VTCZ0647, VTDN0035, and VTDN0036. 
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		 There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
FDA Determined
Cause 2		 Component change control
Action The recalling firm issued letters dated 4/19/2019 via FedEx on 4/19/2019 with proof of delivery to the U.S. customers. The letters sent to foreign countries vary depending on the format required for the country.
Quantity in Commerce 36,640 units
Distribution Worldwide distribution - US Nationwide distribution, including Puerto Rico. There was government and foreign distribution and no military distribution. Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
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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