Reported Jul 20, 2022 · Ongoing
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Zeltiq Aesthetics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zeltiq Aesthetics, Inc · 4410 Rosewood Dr · Pleasanton, CA · 94588-3050
Is this the product you have?
- CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
- Lot codes and dates
- CoolCore REFBRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R
- UDI-DI00816417020179
- Serial Numbers
2,165 of 2,165 codes
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
- Amount recalled
- 3,054 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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