Ulthera Recalls Cellfina Prep Packs Due to Non-Sterile Vacuum Tube
Ulthera Inc is recalling Cellfina Prep Packs because they contain a non-sterile vacuum tube, while the instructions describe using a sterile tube.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a deviation from sterile protocol without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ulthera Inc is recalling 6,562 units of Cellfina Prep Packs, Part No. CP1. The recall was initiated because the product was found to contain a non-sterile vacuum tube. The Instructions for Use (IFU) for the product describe the use of a sterile vacuum tube as part of the procedure setup.
The affected units were distributed worldwide, including in the United States and several European countries: Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, and the UK. The recall covers all lots of the product.
Consumers and healthcare providers should stop using the affected Cellfina Prep Packs and contact Ulthera Inc for further instructions on how to proceed.
The recalled product
- Product
- Cellfina Prep Pack, Part No. CP1
- Manufacturer
- Ulthera Inc
- Affected units
- 6,562
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all
Distribution
Distribution scope not specified by the agency.
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