Recall Z-1396-2016— Bard Peripheral Vascular Inc

Name: FDA recall Z-1396-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-04

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2016-02-04, terminated 2016-08-03. It names one FDA 510(k) clearance: K936194. Product: Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.. Reason: Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-04
Terminated: 2016-08-03
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K936194 — COAXIAL BIOPSY NEEDLEBard Gynecology and Radiology·cleared 1994-03-22

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 TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Reason for recall

Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.

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