The Recall Desk
ModerateFDA (Devices)·Z-0749-2017·Announced 2016-12-21

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.

What this means for you

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
Category
Medical Device — Surgical Supplies
Hazard
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.

Related recalls

Same hazard · infection risk

See all →