FDA-Device2014-09-24Class II
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.
Bard Peripheral Vascular Inc
Hazard
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.
Sold states
Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries.
Affected count
177,760 units
Manufactured in
1625 W 3rd St Ste 109, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2648-2014Don't want to check this manually?
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