Recall Z-1434-2020— Bard Peripheral Vascular Inc

Name: FDA recall Z-1434-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-03

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2020-01-03, terminated 2022-03-17. It names 2 FDA 510(k) clearances: K051158, K040842. Product: Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.. Reason: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Terminated: 2022-03-17
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

Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

Reason for recall

Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

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