CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Check against the official notice below — it lists the full affected range.
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and removing CoolCore parallel plate applicators (model REF BRZ-AP1-063-000) due to an increased rate of complaints involving Paradoxical Hyperplasia, an adverse event that occurred between 2019 and 2021. A total of 3,054 units were distributed across the United States, including all 50 states and Washington D.C., as well as internationally to countries including Canada, the United Kingdom, France, Germany, Spain, Australia, China, and others.
The recall record does not specify a remedy or instructions for what affected consumers should do regarding this product.
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: 3,054 units Lot/code info: CoolCore REF: BRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R UDI-DI: 00816417020179 Serial Numbers: V0632018051020 V0632018051019 V0632018051018 V0632018051013 V0632018051009 V0632018051008 V0632018044020 V0632018024017 V0632018024002 V0632017292006 V0632017117013 V0632017108003 V0632017108001 V0632017100014 V0632016197018 V0632016140020 V0632016140019 V0632016140018 V0632016140017 V0632016140016 V0632016140015 V0632016140014 V0632016140012 V0632016140011 V0632016140008 V0632016140007 V0632016140006 V0632016140004 V0632016140003 V0632016140002 V0632016140001 V0632016139020 V0632016139019 V0632016139016 V0632016139015 V0632016139014 V0632016139013 V0632016139012 V0632016139011 V0632016139009 V0632016139008 V0632016139007 V0632016139006 V0632016139005 V0632016139004 V0632016139003 V0632016139001 V0632016133019 V0632016133018 V0632016133016 V0632016133015 V0632016133011 V0632016133009 V0632016133007 V0632016133004 V0632016133003 V0632016132017 V0632016132016 V0632016132015 V0632016132013 V0632016132012 V0632016132011 V0632016132010 V0632016132009 V0632016132008 V0632016132007 V0632016132006 V0632016132004 V0632016132003 V0632016132001 V0632016131020 V0632016131019 V0632016131018 V0632016131017 V0632016131014 V0632016131013 V0632016131012 V0632016131011 V0632016131009 V0632016131008 V0632016131007 V0632016131006 V0632016131005 V0632016131003 V0632016131002 V0632016127020 V0632016127019 V0632016127016 V0632016127015 V0632016127014 V0632016127012 V06320161270
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.