Medical device recalls Moderate risk

Bard Peripheral Vascular Inc recalls Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biops…

Recall date
July 6, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2547-2016
FDA classification
Class II
Brand / firm
Bard Peripheral Vascular Inc
Sold / distributed
Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.

Why it was recalled

May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

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  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 soft tissue lesions.

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