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U.S. Department of Health and Human Services

Class 2 Device Recall TissueTrans Product Line

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  Class 2 Device Recall TissueTrans Product Line see related information
Date Initiated by Firm June 01, 2017
Create Date August 22, 2017
Recall Status1 Open3, Classified
Recall Number Z-3060-2017
Recall Event ID 77518
Product Classification Syringe, irrigating (non dental) - Product Code KYZ
Product Tissu-Trans Filtron 100, 3-TT-FILTRON 100.

Product Usage:
Intended for fat transfer and liposuction.
Code Information Lot Numbers 12018, 12045, 12076, 12109.
Recalling Firm/
Manufacturer		 Shippert Medical Technologies
6248 S Troy Cir Ste A
Centennial CO 80111-6485
Manufacturer Reason
for Recall		 Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
FDA Determined
Cause 2		 Packaging
Action Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.
Quantity in Commerce 5,188 units total
Distribution Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.
Total Product Life Cycle TPLC Device Report
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.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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