Bard Peripheral Vascular Inc recalls EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numb

Recalled August 14, 2019 · FDA recall Z-2212-2019 · Bard Peripheral Vascular

Hazard

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

Units

239 units

Sold at

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.

Description

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

Product

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Manufacturer(s)

Bard Peripheral Vascular Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →