BARD MAX-CORE Disposable Core Biopsy Instrument recalled over fire hazard

Recall date

September 22, 2017

Source

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

Official notice title

Bard Peripheral Vascular Inc recalls BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18…

Recall number

Z-0044-2018

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific

Why it was recalled

During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.

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 MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.