Recall Z-2547-2016— Bard Peripheral Vascular Inc

Name: FDA recall Z-2547-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-06

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2016-07-06, terminated 2016-11-17. It names one FDA 510(k) clearance: K936194. Product: Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B 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: May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-06
Terminated: 2016-11-17
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 Mixed Product Part Number C1816B 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

May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

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