Z-1431-2020 Class II Terminated
FDA device recall Z-1431-2020 was initiated by Bard Peripheral Vascular Inc on January 3, 2020 and is designated Class II. Reason for recall: Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to o… The recall status is terminated (terminated March 17, 2022). Affected quantity: 12,875 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- January 3, 2020
- Termination Date
- March 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,875 units
Product Description
Reason for Recall
Distribution Pattern
Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.