Bard TruGuide Biopsy Needle Recall for Incorrect Stylet Configuration
Bard Peripheral Vascular Inc is recalling 1,250 TruGuide Disposable Coaxial Biopsy Needles because some units may contain two trocar or two blunt tip stylets instead of one of each.
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, and the hazard involves a configuration error (incorrect stylet count) rather than a high-risk pathogen or structural defect likely to cause serious injury. No injuries or illnesses are reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 1,250 units of Bard TruGuide Disposable Coaxial Biopsy Needles, Part Number C1816B, Lot Number REZK0479. These 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.
The recall was initiated because the product may contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. This configuration error deviates from the intended product specification.
The affected units were distributed nationwide to California, Louisiana, Virginia, Iowa, Arkansas, South Carolina, Pennsylvania, Massachusetts, Illinois, and Missouri. Foreign distribution included Canada, Belgium, Australia, Taiwan, China, and Argentina. Healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Needle
- Affected units
- 1,250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: REZK0479
Distribution
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