—#175132

Product

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K040842, K051158
Affected lot / code info: Lot numbers VTCT0273, VTCT0308, VTCT0309, VTCU0351, VTCU0352, VTCW0451, VTCW0452, VTCW0453, VTCX0485, VTCX0486, VTCX0487, VTCY0548, VTCY0549, VTCY0550, VTCZ0642, VTCZ0643, VTCZ0644, and VTCZ0645.

Why it was recalled

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

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-05-02
Terminated: 2022-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175132. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.