CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Check against the official notice below — it lists the full affected range.
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and removing CoolCurve+ parallel plate applicators (model REF BRZ-AP1-064-000) due to an increased complaint rate for Paradoxical Hyperplasia (HP), an adverse event reported during 2019 to 2021. The recall affects 2,686 units distributed across all U.S. states and territories, as well as multiple countries including Canada, Australia, China, the United Kingdom, France, Germany, and others.
The record does not specify what actions affected consumers should take regarding this recall.
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: 2,686 units Lot/code info: CoolCurve+ REF: BRZ-AP1-064-000 BRZ-AP1-064-000_R UDI-DI: 00816417020193 Serial Numbers: V0642017122012 V0642016285020 V0642016285018 V0642016173010 V0642016173009 V0642016173007 V0642016173005 V0642016173003 V0642016173002 V0642016173001 V0642016167020 V0642016167019 V0642016167018 V0642016167017 V0642016167015 V0642016167013 V0642016167011 V0642016167009 V0642016167007 V0642016167006 V0642016167002 V0642016167001 V0642016160019 V0642016160018 V0642016160017 V0642016160014 V0642016160013 V0642016160012 V0642016160009 V0642016160008 V0642016160005 V0642016160003 V0642016160002 V0642016127020 V0642016127019 V0642016127018 V0642016127017 V0642016127016 V0642016127014 V0642016127013 V0642016127011 V0642016127008 V0642016127006 V0642016127005 V0642016127004 V0642016127001 V0642016125019 V0642016125018 V0642016125017 V0642016125016 V0642016125015 V0642016125014 V0642016125013 V0642016125011 V0642016125010 V0642016125009 V0642016125008 V0642016125007 V0642016125006 V0642016125005 V0642016125003 V0642016124020 V0642016124019 V0642016124018 V0642016124017 V0642016124016 V0642016124005 V0642016124004 V0642016118036 V0642016118031 V0642016118026 V0642016118021 V0642016118017 V0642016118016 V0642016118015 V0642016118014 V0642016118013 V0642016118012 V0642016118009 V0642016118006 V0642016118005 V0642016118003 V0642016118002 V0642016118001 V0642016110020 V0642016110019 V0642016110018 V0642016110016 V0642016110015 V0642016110013 V0642016110012 V0642016110011 V0642016110010 V0642016110009 V
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.