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.
Reported: May 13, 2015 Initiated: April 9, 2015 #Z-1586-2015
Product Description
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.
Reason for Recall
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 7,995 units
- Distribution
- 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.
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 7,995 units.
Why was this product recalled? ▼
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1586-2015.
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