Recall Z-2211-2019 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
| Date | May 2, 2019 |
| Status | Terminated |
| Reason | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. |
| Root cause | Component change control |
| 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. |
| Quantity | 5,298 units |
| 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, E |
| FDA record | Open on fda.gov |