FDA-Device2020-01-01Class II
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Bard Peripheral Vascular Inc
Hazard
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Sold states
Worldwide distribution - US Nationwide distribution and countries of Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific.
Affected count
727,034 units
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2020Don't want to check this manually?
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