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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
Recalled November 1, 2017 · FDA recall Z-0044-2018 · Bard Peripheral Vascular
Hazard
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. · FDA Class II
Units
110,550 units
Sold at
US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
Description
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.
Product
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.
Manufacturer(s)
Bard Peripheral Vascular Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →