Z-1586-2015 Class II Terminated
FDA device recall Z-1586-2015 was initiated by Bard Peripheral Vascular Inc on Apr 9, 2015 and is designated Class II. Reason for recall: The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues. The recall status is terminated (terminated Sep 25, 2015). Affected quantity: 7,995 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2015
- Initiation Date
- Apr 9, 2015
- Termination Date
- Sep 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,995 units
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1586-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026