FDA recall Z-0724-2020

Product

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.

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide distribution and countries of Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific.

Key facts

Status

Terminated

Initiation date

2019-10-25

Report date

2020-01-01

Termination date

2024-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2020