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U.S. Department of Health and Human Services

Medical Device Recalls

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  Medical Device Recalls see related information
Date Initiated by Firm November 14, 2016
Create Date December 13, 2016
Recall Status1 Terminated 3
Recall Number Z-0749-2017
Recall Event ID 75682
Product Cellfina Prep Pack, Part No. CP1
Code Information all
Recalling Firm/
Manufacturer
Ulthera Inc
1840 S Stapley Dr Ste 200
Mesa AZ 85204-6681
For Additional Information Contact Ulthera Customer Service
480-619-4069
Manufacturer Reason
for Recall
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
Action Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at mymerzsolutions@merz.com.
Quantity in Commerce 6562 units
Distribution Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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