Bard TruGuide Biopsy Needle Recall Due to Incorrect Stylet Size
Bard Peripheral Vascular is recalling TruGuide Disposable Coaxial Biopsy Needles because they may contain an incorrectly sized blunt tip stylet that will not pass through the coaxial.
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 defect involves a component that will not pass through the device, representing a functional failure rather than a direct, immediate physical hazard like a sharp edge or toxic material, and no injuries are reported in the source text.
Plain-English summary
Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles. The recall is due to a potential defect where the packaging may contain an incorrectly sized blunt tip stylet that will not pass through the coaxial needle.
The affected product is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue, including the liver, kidney, spleen, lymph nodes, and various soft tissue lesions. The recall involves 2,320 units with Part Number C2016B and Lot Numbers REWL0924, REXA1695, REXB1529, and REXC1632.
The product was distributed in the United States to the following states: SC, CO, MT, PA, MA, TX, MI, VA, OH, CA, GA, WA, MO, KS, TN, IA, FL, and NV, as well as Puerto Rico (PR). Foreign distribution included Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, and the UK. Users should stop using the affected needles and contact the manufacturer for further instructions.
The recalled product
- Product
- Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: 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.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Biopsy Needle
- Affected units
- 2,320
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 (4)
- Part Number: C2016B Lot Numbers: REWL0924
- REXA1695
- REXB1529
- REXC1632
Distribution
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