Bard DuaLok Breast Lesion Localization Wire Recalled for Sterile Barrier Breach
Bard Peripheral Vascular Inc is recalling Bard DuaLok Breast Lesion Localization Wires because portions of the wire may protrude from the packaging, breaching the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a sterile barrier breach, which is a significant quality issue, but the source text does not report any illnesses, injuries, or hospitalizations, placing it in the moderate category for a precautionary recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling the Bard DuaLok Breast Lesion Localization Wire. The recall is being conducted because the product may be at risk of having portions of the wire protruding from the packaging. This condition represents a breach of the sterile barrier.
The affected product codes are LW0037, LW0057, LW0077, LW0107, and LW0137. A total of 177,760 units are involved in this recall. The products were distributed worldwide, including in the United States, Australia, Canada, and various European, Latin American, and Asian Pacific countries.
The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies. The source text does not specify specific consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- 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…
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 177,760
Distribution
Distributed nationwide across the United States.
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