FDA recall Z-0117-2022

Beckman Coulter Inc. · Class II · device

Product

Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

Reason for recall

Missing splash guard which may expose users to hazardous materials. .

Distribution

U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA, MI, MS, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WA, and WV O.U.S.: Canada, China, Spain, France, United Kingdom, Israel, Italy, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Portugal, Qatar, Saudi Arabia, Thailand, Turkey, and Taiwan. Additional O.U.S. added 12/15/2021 - South Africa

Key facts

Status: Ongoing
Initiation date: 2021-07-28
Report date: 2021-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2022