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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 Probesee related information
Date Initiated by FirmMay 02, 2019
Create DateAugust 07, 2019
Recall Status1 Terminated 3 on March 03, 2022
Recall NumberZ-2213-2019
Recall Event ID 83303
510(K)NumberK040842 K051158 
Product Classification Instrument, biopsy - Product Code KNW
ProductEnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Code Information Lot numbers VTCU0342, VTCU0343, VTCU0344, VTCU0345, VTCU0346, VTCU0347, VTCU0348, VTCU0349, VTCU0350, VTCV0372, VTCV0373, VTCV0374, VTCV0375, VTCV0376, VTCV0377, VTCV0378, VTCV0379, VTCV0380, VTCV0381, VTCV0382, VTCV0383, VTCW0448, VTCW0449, VTCW0450, VTCW0457, VTCW0458, VTCW0459, VTCW0460, VTCW0461, VTCW0462, VTCW0463, VTCW0464, VTCW0465, VTCW0466, VTCX0488, VTCX0489, VTCX0490, VTCX0491, VTCX0492, VTCX0493, VTCX0494, VTCX0495, VTCX0496, VTCX0497, VTCX0498, VTCX0499, VTCX0500, VTCX0501, VTCX0502, VTCY0551, VTCY0552, VTCY0553, VTCY0554, VTCY0555, VTCY0556, VTCY0557, VTCY0558, VTCY0559, VTCY0560, VTCY0562, VTCY0561, VTCY0563, VTCY0564, VTCY0565, VTCZ0650, VTCZ0651, VTCZ0652, VTCZ0653, VTCZ0654, VTCZ0655, VTCZ0656, VTCZ0657, VTCZ0658, and VTCZ0659.
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		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
ActionThe 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 Commerce125,292 units
DistributionWorldwide 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 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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