FDA-Device2017-11-01Class II
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.
Bard Peripheral Vascular Inc
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.
Sold states
US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
Affected count
110,550 units
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2018Don't want to check this manually?
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