medical Class II Updated 2019-08-14

Bard Peripheral Vascular Inc recalls EnCor Breast Biopsy Probes, packaged individually in sterile

Recalled Product

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.

Hazard / Issue

There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.

Issued by

FDA

Distribution: Nationwide (United States)

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.

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