CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Check against the official notice below — it lists the full affected range.
Zeltiq Aesthetics is voluntarily discontinuing and removing CoolMax ZELTIQ parallel plate applicators (model BRZ-AP1-080-000) due to an increased rate of complaints about Paradoxical Hyperplasia, an adverse event that occurred between 2019 and 2021. A total of 2,945 units have been affected and distributed across the United States, Puerto Rico, and multiple countries including Canada, the United Kingdom, Australia, and others.
The recall involves specific serial numbers of the applicator devices. According to the recall record provided, no specific remedy or instructions for affected consumers are specified.
Written by software from the official notice below. Not reviewed by a lawyer.
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Reason for recall: Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe. Distribution: U.S. AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: United Arab Emirates, Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Canada, Switzerland, China, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United K Quantity: 2,945 units Lot/code info: CoolMax BRZ-AP1-080-000 BRZ-AP1-080-000-R UDI-DI: 00816417020230 Serial Numbers: V082010246001 V0802018039018 V0802017153007 V0802017138015 V0802017138013 V0802016258020 V0802016258017 V0802016258014 V0802016258012 V0802016258008 V0802016258006 V0802016258003 V0802016235037 V0802016235032 V0802016235030 V0802016235024 V0802016235022 V0802016235017 V0802016235016 V0802016235010 V0802016235002 V0802016229019 V0802016229018 V0802016229012 V0802016229010 V0802016229009 V0802016229008 V0802016229003 V0802016218011 V0802016218009 V0802016217010 V0802016217008 V0802016217005 V0802016217004 V0802016217002 V0802016214036 V0802016214033 V0802016214031 V0802016214029 V0802016214022 V0802016214021 V0802016214013 V0802016214012 V0802016214010 V0802016214009 V0802016214008 V0802016214007 V0802016214006 V0802016214005 V0802016214004 V0802016214003 V0802016214001 V0802016208010 V0802016208009 V0802016208008 V0802016208003 V0802016208002 V0802016207040 V0802016207039 V0802016207038 V0802016207035 V0802016207032 V0802016207031 V0802016207030 V0802016207029 V0802016207027 V0802016207026 V0802016207025 V0802016207024 V0802016207023 V0802016207022 V0802016207019 V0802016207018 V0802016207014 V0802016207013 V0802016207011 V0802016207010 V0802016207008 V0802016207004 V0802016207002 V0802016207001 V0802016201008 V0802016201007 V0802016201006 V0802016201004 V0802016201001 V0802016196019 V0802016196017 V0802016196013 V0802016196012 V0802016196011 V0802016196010 V0802016196008 V0802016196007 V080201619
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.