Terminated

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

FDA Recall Z-2209-2019 · Posted None

Recalling FirmBard Peripheral Vascular Inc

Recall StatusTerminated

Product CodeKNW

Date Initiated2019-05-02

Date Terminated2022-03-03

Product Quantity36,640 units

Reason for Recall

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

Firm Action

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.

Root Cause

Component change control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051158ENCOR 7 GAUGESenorx, Inc. · 2005-05-16 K040842SENORX BIOPSY DEVICE IISenorx, Inc. · 2004-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.