CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Reported: July 20, 2022 Initiated: June 9, 2022 #Z-1350-2022
Product Description
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
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.
Details
- Recalling Firm
- Zeltiq Aesthetics, Inc
- Units Affected
- 2,684 units
- 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.
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000. Recalled by Zeltiq Aesthetics, Inc. Units affected: 2,684 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1350-2022.
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