Z-1348-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2022
- Initiation Date
- June 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 703 units
Product Description
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
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 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. O.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.
Code Information
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 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