CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Check against the official notice below — it lists the full affected range.
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and removing parallel plate applicators for the CoolCurve ZELTIQ Vacuum Applicator (model BRZ-AP1-062-000) due to an increased rate of complaints involving Paradoxical Hyperplasia, an adverse event reported between 2019 and 2021. A total of 703 units were distributed across the United States, Puerto Rico, and multiple international locations including Canada, the United Kingdom, Australia, and many others.
The recall involves specific serial numbers of the affected applicators. The source document does not specify a remedy or what action 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: 703 units Lot/code info: CoolCurve REF: BRZ-AP1-062-000 BRZ-AP1-062-000_R UDI-DI: 00816417021008 Serial Numbers: V06222012073001 V0622017039030 V0622016307004 V0622016196017 V0622012291003 V0622012289006 V0622012289004 V0622012289002 V0622012285005 V0622012285002 V0622012284009 V0622012284001 V0622012283003 V0622012282002 V0622012279006 V0622012279005 V0622012278001 V0622012277004 V0622012262002 V0622012258007 V0622012258002 V0622012255002 V0622012254001 V0622012250004 V0622012212001 V0622012210007 V0622012201001 V0622012193004 V0622012192004 V0622012178002 V0622012173001 V0622012170007 V0622012167003 V0622012167002 V0622012165008 V0622012163002 V0622012161005 V0622012161003 V0622012161002 V0622012160001 V0622012159007 V0622012159002 V0622012156004 V0622012153006 V0622012152001 V0622012150004 V0622012150002 V0622012150001 V0622012145003 V0622012145002 V0622012144001 V0622012143009 V0622012143008 V0622012143007 V0622012143006 V0622012143005 V0622012143002 V0622012140002 V0622012139005 V0622012139003 V0622012139002 V0622012139001 V0622012138003 V0622012137003 V0622012135003 V0622012135002 V0622012135001 V0622012130004 V0622012130003 V0622012129005 V0622012129002 V0622012129001 V0622012128005 V0622012128003 V0622012123002 V0622012123001 V0622012122001 V0622012121007 V0622012121006 V0622012121005 V0622012121004 V0622012121003 V0622012121002 V0622012121001 V0622012118002 V0622012118001 V0622012117001 V0622012116004 V0622012116002 V0622012116001 V0622012115005 V0622012115003 V0622012115002 V0622012114005 V
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.