Bard Peripheral Vascular Inc recalls Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intend…

Recall date

February 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1396-2016

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

U.S. distribution to the following; SC, CO, MT, PA, MA, TX, MI, VA OH, CA, GA, WA, MO, KS, TN, IA, FL, NV, PR. Foreign distribution to the following; Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, UK.

Why it was recalled

Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.