CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Check against the official notice below — it lists the full affected range.
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and removing CoolFit ZELTIQ parallel plate applicators (model BRZ-AP1-066-000) due to an increased complaint rate for Paradoxical Hyperplasia, an adverse event reported during 2019 to 2021. A total of 2,684 units have been distributed across the United States, Puerto Rico, and multiple international locations including Canada, the United Kingdom, France, Germany, Australia, China, and the United Arab Emirates.
The specific serial numbers affected by this recall are listed in the record, along with reference codes BRZ-AP1-066-000 and BRZ-AP1-064-000_R. The source document does not specify a remedy or instructions for what affected consumers should do 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: 2,684 units Lot/code info: CoolCurve REF: BRZ-AP1-066-000 BRZ-AP1-064-000_R UDI-DI: 00816417020216 Serial Numbers: V0662016146015 V0662016146014 V0662016146010 V0662016146007 V0662016146002 V0662016145016 V0662016145015 V0662016145010 V0662016145009 V0662016145008 V0662016145005 V0662016145004 V0662016145002 V0662016144019 V0662016144017 V0662016144016 V0662016144015 V0662016144014 V0662016144012 V0662016144009 V0662016144007 V0662016144003 V0662016140038 V0662016140037 V0662016140036 V0662016140035 V0662016140033 V0662016140032 V0662016140031 V0662016140030 V0662016140029 V0662016140028 V0662016140027 V0662016140024 V0662016140023 V0662016140021 V0662016140020 V0662016140018 V0662016140017 V0662016140014 V0662016140013 V0662016140011 V0662016140009 V0662016140007 V0662016140004 V0662016140003 V0662016140002 V0662016140001 V0662016137020 V0662016137019 V0662016137018 V0662016137016 V0662016137015 V0662016137014 V0662016137013 V0662016137012 V0662016137011 V0662016137010 V0662016137008 V0662016137006 V0662016137004 V0662016137001 V0662016123020 V0662016123017 V0662016123016 V0662016123009 V0662016123007 V0662016123006 V0662016123005 V0662016123003 V0662016123002 V0662016120020 V0662016120019 V0662016120018 V0662016120015 V0662016120011 V0662016120010 V0662016120009 V0662016120008 V0662016120007 V0662016120004 V0662016120003 V0662016113020 V0662016113019 V0662016113017 V0662016113015 V0662016113014 V0662016113013 V0662016113012 V0662016113010 V0662016113009 V0662016113008 V0662016113007 V0662016113006 V0
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.