Recall Z-2211-2019— Bard Peripheral Vascular Inc

Name: FDA recall Z-2211-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-02

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2019-05-02, terminated 2022-03-03. It names 2 FDA 510(k) clearances: K051158, K040842. Product: 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.. Reason: There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Terminated: 2022-03-03
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

2 on FDA's record

K051158 — ENCOR 7 GAUGESenorx, Inc.·cleared 2005-05-16
K040842 — SENORX BIOPSY DEVICE IISenorx, Inc.·cleared 2004-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.