Zeltiq Aesthetics, Inc Recall 90331
Description: CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Zeltiq Aesthetics, Inc Recall 90331 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1346-2022 |
| Event ID | 90331 |
| Event Description | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 |
| Product Type | Devices |
| 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 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. |
| Quantity | 2,945 units |
| Recall Reason | 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. |
| Device Classification | 20220720 |
| Device Code Info | CoolMax BRZ-AP1-080-000 BRZ-AP1-080-000-R UDI-DI: 00816417020230 Serial Numbers: V082010246001 V0802018039018 V0802017153007 V0802017138015 V0802017138013 V0802016258020 V0802016258017 V0802016258014 V0802016258012 V0802016258008 V0802016258006 V0802016258003 V0802016235037 V0802016235032 V0802016235030 V0802016235024 V0802016235022 V0802016235017 V0802016235016 V0802016235010 V0802016235002 V0802016229019 V0802016229018 V0802016229012 V0802016229010 V0802016229009 V0802016229008 V0802016229003 V0802016218011 V0802016218009 V0802016217010 V0802016217008 V0802016217005 V0802016217004 V0802016217002 V0802016214036 V0802016214033 V0802016214031 V0802016214029 V0802016214022 V0802016214021 V0802016214013 V0802016214012 V0802016214010 V0802016214009 V0802016214008 V0802016214007 V0802016214006 V0802016214005 V0802016214004 V0802016214003 V0802016214001 V0802016208010 V0802016208009 V0802016208008 V0802016208003 V0802016208002 V0802016207040 V0802016207039 V0802016207038 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| Center Classification Date | 20220711 |
| Recall Initiation Date | 20220609 |
| Termination Date | 3 V0802012291103 V0802012289103 V0802012285105 V0802012285103 V0802012285102 V0802012285101 V0802012283101 V0802012282102 V0802012279105 V0802012279103 V0802012279101 V0802012278104 V0802012278103 V0802012278102 V0802012278101 V0802012277102 V0802012276103 V0802012276102 V0802012276101 V0802012268103 V0802012268102 V0802012264105 V0802012264103 V0802012264101 V0802012263106 V0802012263103 V0802012263102 V0802012263101 V0802012262101 V0802012255101 V0802012254105 V0802012254104 V0802012251101 V0802012250104 V0802012243104 V0802012243103 V0802012242107 V0802012242104 V0802012242103 V0802012242102 V0802012241106 V0802012241102 V0802012240107 V0802012240105 V0802012240101 V0802012238101 V0802012237109 V0802012237107 V0802012237106 V0802012237105 V0802012237103 V0802012237102 V0802012235109 V0802012235108 V0802012235105 V0802012235103 V0802012235102 V0802012233106 V0802012233104 V0802012230109 V0802012230106 V0802012230105 V0802012230103 V0802012230102 V0802012230101 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| Recalling Firm | Zeltiq Aesthetics, Inc |
| Initial Notification | Letter |
| Similar To |