Recall Z-2648-2014— Bard Peripheral Vascular Inc

Name: FDA recall Z-2648-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-26

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2014-08-26, terminated 2015-03-06. It names one FDA 510(k) clearance: K935457. Product: Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.. Reason: Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2014-08-26
Terminated: 2015-03-06
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K935457 — LOCALIZATION WIRE OR MARKER - SURGICALBip USA, Inc.·cleared 1994-02-17

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 DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.

Reason for recall

Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.

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