{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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"firm_fei_number": "3007215625", "recalling_firm": "Zeltiq Aesthetics, Inc", "address_1": "4410 Rosewood Dr", "city": "Pleasanton", "state": "CA", "postal_code": "94588-3050", "additional_info_contact": "Nicole Katz\n862-261-7084", "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.", "root_cause_description": "Unknown/Undetermined by firm", "action": "On 06/09/2022, the Recalling firm started sending an \"URGENT: MEDICAL DEVICE RECALL\" Letter via FedEx Overnight service to customers informing them discontinue and return all CoolSculpting Parallel Plate Applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit) due to an increase in the rate of complaints for Paradoxical hyperplasia (PH) (also referred to as Paradoxical Adipose Hyperplasia-PAH) during 2019 to 2021 timeframe.\n\nCustomers are instructed to:\n1. If you have the affected applicators, discontinue further use and quarantine products prior to return.\n2. Monitor patients that have undergone a procedure per your normal clinical practice. .\n3. Conduct a physical count of the affected applicators in your possession and record the count on the enclosed Business Response Form.\n4. Send the Business Response Form to Qualanex, LLC. via fax or email within five business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if no recalled product is present.\n5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to:\nQualanex, LLC.\n1410 Harris Road\nLibertyville, IL 60048\n5. Please do not return any products that are not the subject of this recall to this address.\n\nFor questions or assistance, contact:\nProduct Returns\nContact Qualanex, LLC\n1-800-505-9291, \n7:00am - 4:00pm CST or \nrecall@qualanex.com\n\nAdverse Events/Product Complaints\nContact ZELTIQ at:\n1-800-624-4261, 8am 5pm CST\n\nMedical Information\nContact ZELTIQ at:\n1-800-678-1605 option #2, 8:30 am 5:00 pm EST\n or IR-Medcom@allergan.com\nFor after hours assistance, please leave a voicemail or email. A response will be provided within 48 hours.", "product_quantity": "2,945 units", "distribution_pattern": "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.\n\nO.U.S.: United Arab Emirates, Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Canada, Switzerland, China, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, The Republic of Korea, Kuwait, Lebanon, Luxembourg, Latvia, Mexico, The Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Uruguay, Venezuela, and South Africa.", "openfda": { "k_number": [ "K183514", "DEN090002", "K181740", "K133212", "K160259", "K142491", "K171069", "K162050", "K120023", "K172144", "K193566", "K233732", "K212707", "K151179" ], "registration_number": [ "3028011", "3002807401", "3012441529", "3011837770", "2011068", "3009974688", "3007215625", "3009736547", "3020978007", "1000150986", "3027605507", "9617229", "3017132875", "9681572", "3014214244", "3008959444", "3001415205", "3003890514", "3023281311" ], "fei_number": [ "3003263857", "3006108784", "3002807401", "3012441529", "3011837770", "2011068", "3009974688", "3007215625", "3009736547", "3020978007", "1000150986", "3011913386", "3027605507", "3017132875", "3014214244", "3008959444", "3001415205", "3003890514", "3023281311" ], "device_name": "Dermal Cooling Pack/Vacuum/Massager", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4340", "device_class": "2" } } ] }