EnCor 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.
This recall has been terminated (originally issued May 2, 2019).
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- May 2, 2019
- Terminated
- March 3, 2022
- Recall Number
- Z-2213-2019
- Quantity
- 125,292 units
- Firm Location
- Tempe, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
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.
Lot / Code Info
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.
Root Cause
Component change control
Action Taken
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.