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Recall Observatory FDA recall evidence

Device product

BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.

Z-1586-2015

April 09, 2015

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 70952
Status
Terminated
Classification
Class II
Quantity
7,995 units
Official record key
device-enforcement:Z-1586-2015

Official wording

Reason: The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.

Code information: Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV and the countries of: France, Mexico, Netherlands, Panama, United Kingdom, Switzerland, Spain, Poland, Norway, Iceland, Italy, Greece, Finland, Belgium, Germany, Austria, China, Taiwan, Singapore, Korea, Australia, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.